Chapter 09: Three Small Business Grants to Advance Onco-Fertility
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Description
In this chapter, Dr. Schover discusses three projects she developed with NCI small business grants when she returned to MD Anderson in 1999 from the Cleveland Clinic, all of which were geared to providing accurate, timely information about fertility preservation for different populations of cancer patients. The first study (1999) surveyed physicians for their attitudes and practices working with patients around the issue of sperm banking. A second part of that study involved creating interventions: guidance for both male patients and for oncology professionals to increase awareness and use of sperm banking. She talks about the challenges evaluating this study and the importance of having strong networks among clinicians to ensure a robust population for a study. Dr. Schover also discusses why MD Anderson had not invested in in-house sperm banking services.
Next, she talks about the second study (2004) and its focus on providing an educational and counseling tool for women with regards to sexuality and fertility. The interventions included a website and a randomized trial to determine the effectiveness of in-person counseling versus 24/7 online access to information and guides to self-help in decision making. She then explains that the third grant focused on creating a similar reproductive health resource for men.
Next, Dr. Schover notes that she used an American Cancer Society grant to develop an online intervention for couples after prostate cancer treatment.
Identifier
SchoverL_02_20181004_C09
Publication Date
10-4-2018
City
Houston, Texas
Interview Session
T.A. Rosolowski, PhD, Oral History Interview, October 04, 2018
Topics Covered
The University of Texas MD Anderson Cancer Center - Building the Institution; MD Anderson Product Development and IP; Discovery, Creativity and Innovation; Finance, Entrepreneur, Biotechnology; The Researcher; Discovery and Success; Professional Practice; The Professional at Work; Collaborations; Critical Perspectives on MD Anderson; Definitions, Explanations, Translations; Overview; Understanding Cancer, the History of Science, Cancer Research; The History of Health Care, Patient Care; Building/Transforming the Institution; Survivors, Survivorship; Patients, Treatment, Survivors; Funny Stories
Transcript
T.A. Rosolowski, PhD:
Well, you had also wanted to, or I had wanted to follow up a little bit more on the issue of the research that you were doing with online interventions, and this was connected with the start-up grants. Maybe you could talk a bit about the significance of the fact. You mentioned that you were the first person in Behavioral Science to actually get grants, start-up grants.
Leslie Schover, PhD:
Small business grants.
T.A. Rosolowski, PhD:
Small business grants, I’m sorry, I’m sorry, yes.
Leslie Schover, PhD:
That’s okay. Yeah.
T.A. Rosolowski, PhD:
I’m jumping ahead there.
Leslie Schover, PhD:
One of the things that happened was the National Cancer Institute’s Small Business Grant Office, put out a request for applications for cancer communication grants, which was a really different format. It was a combination of what they called an R-25 and an SBIR, phase 1 and 2. So actually, you had to write the grant with three phases, and the first phase was kind of the background research to understand why it was important to do the actual first and second phases. The first phase of a small business grant is kind of feasibility studies, and the second phase is actually creating and testing some kind of a product, a drug or in this case it was a CD-ROM on sperm banking, with a portion for healthcare professionals and a portion for patients.
T.A. Rosolowski, PhD:
Let me just quick, as you --when did this first call for applications come about?
Leslie Schover, PhD:
I think it was very soon after I came back to MD Anderson, in 1999, because I think the grants started in 2000.
T.A. Rosolowski, PhD:
Okay, okay. So, a very cool opportunity. Had you already been thinking about some of these things before the application call?
Leslie Schover, PhD:
Yeah. I had just done a study, just before I left the Cleveland Clinic, a survey of young adult people with cancer, who had been diagnosed at, I think age 35 or younger, and about their desire to have a child retrospectively, at the time when they were diagnosed with cancer, and currently. So, that was one of the first surveys of its type and later on, a lot of other people did similar surveys but people hadn’t really been asking young cancer survivors, young adults, whether they wanted to have children or not, and one of the findings in our survey was that people who were childless when their cancer was diagnosed, basically 75 percent of them wanted to have a child. So, there was not a big group of people who said oh, I’ve had cancer, now I don’t want to be a parent; that was a fairly small group. And then you know, there was also a lot of people who had already managed to have one or more children before they were diagnosed with cancer, and they were less, a little bit less distressed, even if their family building had been interrupted. But there also was a fair amount of distress of people who had wanted more than one child and had a cancer diagnosis and were not able to have a second child or third child.
T.A. Rosolowski, PhD:
So what was the intervention you were envisioning at that point, when you made those discoveries?
Leslie Schover, PhD:
Well, one of the things that really bothered me was that I felt like patients weren’t being given timely, accurate information about sperm banking, and it was just the beginning of female fertility preservation. Sperm banking had been around for a long, long time, and the Cleveland Clinic in particular, had a very active sperm bank, and a lot of research on the effect of cancer treatment on sperm quality, and yet it seemed to me that there were a lot of people who were eligible to bank sperm and weren’t getting the information they needed. So the first part of that grant was actually two parallel studies and we collaborated between the Cleveland Clinic and MD Anderson, since I was kind of newly between the two. We surveyed a number of oncologists about their attitudes about talking to patients about sperm banking, and we surveyed a number of fairly recent male patients about whether they had banked sperm or not and if not, why not. We found that indeed, there was a big information gap. And also a finding that’s been replicated a lot since, which is that oncologists tend to cherry-pick who they talk to, whether it’s sperm banking or fertility preservation.
T.A. Rosolowski, PhD:
What’s that about?
Leslie Schover, PhD:
Well, it’s a variety of issues. If somebody is not married, they may not bring it up. If somebody already has children, they may assume they don’t want any more children and they don’t bring it up. If somebody has a bad prognosis and really aggressive disease, they don’t bring it up. If somebody, if they perceive that somebody is financially strained and wouldn’t have the money to do these things, since they have a fair number of out of pocket costs, especially for women, but even sperm banking, they may not bring it up. So instead of bringing it up to everyone, which I think is the proper standard --and which has certainly been the practice guideline starting in 2006, from ASCO-- and letting the patient decide whether they’re interested or not, what we found is that oncologists tend to only bring the topic up selectively. That was what we corresponded to, what patients remembered too. About a quarter of patients said that the main reason they hadn’t banked sperm was that nobody told them about it in time. I’m not sure how much that’s improved, after the 2013 ASCO guidelines came out. No, I guess it was after the first set of ASCO Oncofertility Guidelines came out in 2006, which basically said all patients of reproductive age should be told about any risks to their fertility and offered the chance for fertility preservation. Two surveys were done, both of which found that only half of patients, even two, three or four years later, after the guideline, recall being told about the potential risk to their fertility. So it’s really hard to change practice.
T.A. Rosolowski, PhD:
Yeah, no kidding, no kidding. Now, did you—so did you go through and create some sort of intervention based on this information?
Leslie Schover, PhD:
We did and it was so long ago that it was actually on a CD-ROM originally, and it’s now part of the information that was in the intervention, is now mostly part of our Will2Love self-help programs for men and women. But that intervention was only for men, and what we did was we created a whole educational tool, with some decision parts of it for men, and some advice on, for example, ‘for me it’s often really difficult’: you’re ill with cancer, you may not be feeling good, and someone tells you, you have to go to the sperm bank, and you essentially have to masturbate to produce a semen sample, and it’s often really off-putting and a really negative experience for men. So we had some advice for men about how to make it easier on themselves when they went to the sperm bank, to make sure that if the room wasn’t going to be soundproofed, that they maybe had some music that they liked. It was before the age when it was so easy to get erotic materials on the Internet, but a lot of sperm banks would have old thumbed over, X-rated magazines, and they would debate whether it was okay to give them to someone under 18, without parental consent. I think things have changed a lot with that. You know, we talked about how some sperm banks will allow you to go into the room with a partner, but you can’t use intercourse, you can only use hand stimulation to orgasm, because you can’t contaminate the samples. There are all kinds of issues like that, but mainly, what we wanted to do was help men understand their cancer could damage their fertility, and what are their options, and how much would it cost, and what would the process be like, and all those things. Then on the professional side, we also had some guidance for oncology professionals, on how to talk to patients about the topic without being embarrassed, and what were some of the issues that you should bring up to every patient. We also made—this was our first attempt at making videos with actors and unfortunately, I wasn’t present when they shot this set of videos and some of them came out very well and some of them came out a little hinky. So we actually, I don’t think we still use any of that original set of videos in our interventions now, because we’ve gotten much better at video production.
T.A. Rosolowski, PhD:
So when you said hinky, did you mean the quality, or were they just, the scenarios didn’t come across well?
Leslie Schover, PhD:
The actors weren’t very good or they muffed their lines, or they didn’t sound real, you know things like that.
T.A. Rosolowski, PhD:
Right, not exactly confidence-inspiring for the viewer.
Leslie Schover, PhD:
They weren’t bad but they weren’t as good as they could have been, so.
T.A. Rosolowski, PhD:
So what was the result, I mean when you started to put these into use?
Leslie Schover, PhD:
Well, one of the problems was that we had a terrible time doing the evaluation part of that study. What we had proposed was that we would get a bunch of men who were in the decision process of whether to bank sperm or not, and we would randomize them as to whether they saw the intervention or not, or before or afterwards. We could not get the clinicians to send the men at the right time, and we had people running all over MD Anderson, trying to find these patients, and we ended up doing some very small studies, like with 20 patients and 20 residents and fellows, and I was very disappointed. We tried a couple of different times, different ways, and we just could not get the men at the right time, before they had already made a decision that they did or didn’t want to bank sperm.
T.A. Rosolowski, PhD:
So what was that about? Why were there these obstacles?
Leslie Schover, PhD:
Well I think part of it is when you’re doing a study that’s cancer-center wide, and you don’t have one or two clinicians who control a lot of the patients and care about the study, but you’re dependent on the kindness and memory of you know, 50 different clinicians, it’s very difficult to recruit, and so I think that was one issue. Another issue is that a lot of men may have made their decision relatively quickly. Either they did or didn’t want to bank sperm. So it was hard to catch them in the decision process. So I thought in the end, we had created a nice little tool, but we couldn’t validate it in the way that I really wanted to, which was very frustrating.
T.A. Rosolowski, PhD:
Now a question I had, you know kind of a related issue, was the whole issue of sperm banking at MD Anderson, because as far as I understand, the institution does not provide that service at this point.
Leslie Schover, PhD:
It’s outsourced.
T.A. Rosolowski, PhD:
It’s outsourced. And so maybe you could provide some perspective on what that’s all about, and the pros and cons of outsourcing.
Leslie Schover, PhD:
Well, ideally, it’s really nice to have sperm banking internally, so patients don’t have to either go themselves or have their samples transferred to another lab. One of the issues is here in Houston, Larry Lipschultz, who is a urologist at Baylor, he may be about to retire finally, but he’s a very world famous male infertility specialist. He and Dorrie Lamb, who recently left Houston but was here for many years, she’s a PhD scientist, had a very big Andrology Lab and fertility program, and so it seemed kind of silly, I think, to duplicate that at MD Anderson, because we could just send people down the street. Also, there’s a liability cost, because if you have a sperm bank, you have to make sure that your freezers aren’t going to decompensate and that you don’t mix up somebody’s sample. So you know, it’s a fairly big administrative task to have a sperm bank as well. So now I think that not only is there still the Baylor alternative, but I think there’s a private infertility program in town who also offers sperm banking. A lot of programs across the country will collect the sample and get it ready to freeze and then they’ll send it for long-term storage, to one of a few centralized sperm banks too.
T.A. Rosolowski, PhD:
So is that process pretty well worked out at MD Anderson? I mean, once a patient actually does get the information, does make the decision, is that a smooth process for the patients?
Leslie Schover, PhD:
Well, I think what happens now is we have a reproductive endocrinologist and a nurse clinician who work with women patients, and I think they often end up fielding the male sperm banking as well. To tell you the truth, I haven’t spoken with Dr. Woodard about what she’s doing with the sperm banking in the last year or so. I’m not sure how it’s working out now, but I think they mostly have been referring men out to one of the other labs in town. I do know—one of my friends who was an oncologist here for many years, told me a story about how he had a young patient who was going to start chemotherapy the next day, so you know, you want to at least try to bank one sample. This poor young man was in his hospital room bathroom and his mother was there, and the mother kept knocking on the door and going, “Are you done yet?” Finally, my friend, the oncologist, pulled her out of the room and said, “Let me take you downstairs for coffee or you’re never going to have any grandchildren.” [both laugh]
T.A. Rosolowski, PhD:
Oh, yeah, no kidding, the poor guy.
Leslie Schover, PhD:
Yeah. I mean it’s bad enough at the sperm bank but it’s, you know really hard in your hospital room or in your hotel room, where there’s often not a lot of privacy. Some banks have mail-in kits, but the sample can get degraded that way. So if there’s a way to get it over to the lab within the hour and preserve it right away, that’s always optimal.
T.A. Rosolowski, PhD:
So what makes sense now, in terms of telling the story, because I want you to tell the story of how the idea for Will2Love came about. So how did that start to take root in your mind and how is it connected up with this work you were doing with interventions.
Leslie Schover, PhD:
Yeah. Well that was the first of our three small business grants and when I got that first grant, Dr. Gritz, my department chair, said to me, “What? What kind of a grant is this? I never heard of a small business grant.” She definitely, at first thought it was something lesser, like less prestigious than a normal NCI grant. Of course now everybody wants small business grants and it’s a much different climate, but the idea of a small business grant is that Congress has the National Institutes of Health allocate a certain amount of money every year for small business grants and the idea is that these grants support projects that could result in a commercial product. Most of them are things like drugs or medical devices, but there are some more behaviorally oriented ones too, and the idea was that if we created this patient and professional training and education product, that it could some day be part of a small business that would commercialize it. So that was the first of three of those grants that we got and each of the grants we got were what they call fast track grants, which means many people apply for the feasibility phase 1 of a small business grant and then, if they achieve their milestone and do well with that, then they can apply for phase 2, where you actually create the product. But we were successful in getting fast track grants where you actually apply for phase 1 and 2 at the same time, and you still have to complete your milestones with phase 1, before they will give you the second, bigger shot of money, but you’ve already gone through the initial process. The next one we got was actually a grant for women and the idea—by that time the Internet was something that people were using to look at health information and you know, and understand medical conditions. So that grant, the idea was to create a combined educational and counseling tool for women that would cover sexuality and fertility, and we were working with an outside small business partner. MD Anderson was the academic partner and the small business actually owns the grant, but the bulk of the money ended up going to MD Anderson, because my small business partner was actually creating the programming in graphics, and I was writing the material and helping with the pictures and illustrations and videos and things like that, that went into the educational and counseling intervention.
T.A. Rosolowski, PhD:
What’s the name of the partner company?
Leslie Schover, PhD:
The partner company… Oh, dear, I’m just going to have…
T.A. Rosolowski, PhD:
It’s fine, we can put it in.
Leslie Schover, PhD:
Yeah. I should know that so well.
T.A. Rosolowski, PhD:
Not to worry.
Leslie Schover, PhD:
It’s Digital Health, Digital Health Incorporated, but I’ll check that for you. The owner of that company, Paul Martinetti, is an MD who did an internship and then started doing a residency, went into, was a very early adopter of health IT essentially, marketing and information and stuff.
T.A. Rosolowski, PhD:
When did you guys submit this particular grant approximately?
Leslie Schover, PhD:
Well we had, I think it was we had finished the first one, so probably around 2004 or something, or 2005.
T.A. Rosolowski, PhD:
So how did this, how did it evolve?
Leslie Schover, PhD:
Well that one was we—I think we did a much better job of doing all the things we were supposed to do. We created a website and we did a randomized trial where women either got the website by itself or the website plus three in-person sessions of counseling. We found that women in both groups, using questionnaires, pre, post and follow-up, had improved sexual function and satisfaction. Also, it was really interesting because women in the two groups spent an equivalent amount of time on the website. The average person spent about two and a half hours, which to me, as a psychologist, didn’t seem like very much, but if you talk to website people that’s considered pretty good. The counseled women spent pretty much all of that time during the first three months of the study, which were the active treatment months, and then during the six months of follow-up they hardly looked at the website at all, whereas the self-help group kept on using the website, so their time of use was stretched over a longer period, and they kept improving their scores over time, whereas the counseled group backslid a little bit. So by the time we got to the six-month follow-up mark, both groups were fairly equal, they were both above their baseline levels, but the trajectory of how they got there was different. We also found that women had improved quality of life and I think reduced sexual distress, if I’m remembering correctly. So the measures all kind of came together.
T.A. Rosolowski, PhD:
Very interesting.
Leslie Schover, PhD:
It was a fairly small study. I think we ended up having 58 women and they all had had either breast or GYN cancer.
T.A. Rosolowski, PhD:
So, was this a project that began getting you thinking about maybe some kind of comprehensive approach to helping organizations and patients get this? How did that start tracking you to your own company?
Leslie Schover, PhD:
Well, I think all along the way, what my goal was really, I wanted there to be something that you could access on the Internet as a patient, that would be there 24-7 and have accurate information. And not just information but also self-help suggestions and guidance on what medical options were there. I didn’t think, until much later, about some of the things that we’ve added, like working with organizations or professional training. Although somewhere in there, and I think it was around 2007 or 2008, was when I had put together this major business proposal to have a reproductive health program at MD Anderson. So you know, that was something that I was thinking about on an organizational level. I think I had told you that story last time, how we got help from the Business Office, put together and 80-page proposal, and then Dr. Burke [oral history interview] said, “Great idea but we don’t have any money for this, so do it with existing resources.” We couldn’t figure out how to get started and finally went to Dr. Mendelsohn [oral history interview], who said he would help us.
T.A. Rosolowski, PhD:
Right. But that was—I mean, even though that didn’t pan out for the institution, I’m sure that was—
Leslie Schover, PhD:
Well we did get a couple of things from the institution.
T.A. Rosolowski, PhD:
Right. The recruiting funds and all of that. But I mean looking at the comprehensive kind of program probably helped you organize your thinking.
Leslie Schover, PhD:
Yeah it did.
T.A. Rosolowski, PhD:
Yeah, about a company.
Leslie Schover, PhD:
Well, and then we got a third small business fast track grant that was the male sexuality piece, that was the one piece that was missing. We had sexuality and fertility, male and female. So we created a parallel kind of website for men and you know, we worked a lot with the sexual medicine clinic, with Dr. [Run] Wang, and we had our own nurse clinician who was paid for by the grant, who worked with the men in the clinic. We tried to supplement what he was doing with giving them medical treatments, with some counseling and education, and we did a couple of different studies from that and again, did find, in the more final study we did, that men also benefited. I also had a study along the way that was funded by the American Cancer Society, to create an online intervention for couples after prostate cancer. We compared the Web intervention with the same content presented in, in-person sessions, and we found they were both effective and equivalent. The Web intervention only had email contact with a therapist, as opposed to the in-person intervention. That was also an important part of this, and we had first piloted that intervention as a more traditional, in-person intervention. So we were developing these kind of sex therapy for different kind of cancer interventions and how to actually present them online, et cetera.
Recommended Citation
Schover, Leslie PhD and Rosolowski, Tacey A. PhD, "Chapter 09: Three Small Business Grants to Advance Onco-Fertility" (2018). Interview Chapters. 1500.
https://openworks.mdanderson.org/mchv_interviewchapters/1500
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