Rectal CancerNCT00712751
The Sexual Health of Rectal Cancer Patients
An observational study of Rectal Cancer and Rectum, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial summary
We know that treatment for rectal, colorectal or anal cancer can impact sexual function. This study aims to learn: How the treatment affects emotional and social well-being. How a new sexual health educational program affects you. Cancer patients seek education for lots of reasons. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Rectal Cancer, Rectum
- What is being tested?
- questionnaires and CSI-SH- Cancer Survivorship Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 149 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Jun 2008to 21 Nov 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Colorectal patients
Who may be able to join
- At least six months post radiation and/or surgery for stage I-III rectal adenocarcinoma or rectosigmoid for cancer with an anastomosis at 15 cm or below and completed treatment
- At least six months post radiation and/or chemotherapy for anal cancer.
- Have no evidence of disease or recurrence
- For women indicate Indicate moderate satisfaction or below on their overall sexual life (a score of "4" or lower on the question "Over the past 4 weeks, how satisfied have you been with your overall sexual life?"
- For men indicate, and a score of "3" or lower on the question "How would you rate your confidence that you could get and keep an erection" for men) and a score of "2" or higher on the question "How much does this problem bother you?
- In the judgment of the consenting professional interventionists, able to communicate in English well enough to work with English speaking and complete the study assessments.
- Age 21 years or older.
Who cannot join
- Significant cognitive or psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in a psychotherapeutic intervention.
- Are actively participating in protocol 06-151
- Participated in focus group or qualitative interview.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mount Sinai Hospital
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: The Sexual Health of Rectal Cancer Patients: A Pilot Study
We know that treatment for rectal, colorectal or anal cancer can impact sexual function. This study aims to learn:
- How the treatment affects emotional and social well-being.
- How a new sexual health educational program affects you.
Cancer patients seek education for lots of reasons. It often helps them cope because they can express their feelings with a trained professional. This study is open to individuals who have been treated for rectal, colorectal or anal cancer. It involves a new type of sexual health counseling program. It will teach participants skills that they can use to improve their sex lives. These skills may also improve physical and emotional well-being. We will compare the new type of sexual health program with the standard care patients receive after treatment for rectal, colorectal or anal cancer.
Read the detailed description
This is a two year randomized clinical trial examining the feasibility, tolerability, acceptability (including adherence) and efficacy of an intervention designed to improve sexual functioning of survivors of rectal cancer.
We have completed enrollment of female patients and are currently collecting follow up data. Recruitment for male patients is ongoing. Male participants will now be randomized in a 3:1 ratio to either the intervention condition (n = 40) or the control condition (n = 40).
- Conditions
- Rectal Cancer, Rectum
- Being tested
- questionnaires, CSI-SH- Cancer Survivorship Intervention
- Keywords
- Rectum, Quality of Life, Sexual Health, 08-073
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesBehavioural
Participants randomized to the Usual Care arm will receive standard care . For women, this is defined as the care that participants who are not in the intervention receive; we will ask these participants what psychosocial care they are receiving to track usual care. For men, "usual care" will consist of a standardized referral to the men's Sexual Medicine Program at MSKCC and written information in the form of the American Cancer Society (ACS) booklet on Sexuality after Cancer. Individuals randomized to Usual Care will not receive any additional counseling sessions from the study interventionists until they are done with the follow up interviews and then it will be offered to them. Follow up questionnaires will assess all study participants at 4 and 8 months after baseline.
CSI-SH- Cancer Survivorship InterventionBehavioural
This involves four 1-hour individual sessions with three additional telephone booster/review sessions provided in between the four sessions. Sessions can be completed in person or conducted over the phone. Although every effort will be made to complete the booster session in between counseling sessions, if the patient is unavailable to complete the booster calls they may be skipped. Sessions one and two will focus on rehabilitation techniques and tools will be provided and discussed with participants during these first two sessions.
| Study group | Role | What they receive |
|---|---|---|
| 1 | usual care (UC) which is the standard care that patients receive Receives: Behavioral: questionnaires | |
| 2 | Cancer Survivorship Intervention-Sexual Health (CSI-SH)plus Usual Care (US) Receives: Behavioral: CSI-SH- Cancer Survivorship Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Female Sexual Functioning Index (FSFI) Total Score for Women From Baseline to Follow-up 1
The FSFI (Female Sexual Functioning Index) is a brief, self-report measure of female sexual function. The 19 items use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual function. The total score for the Female Sexual Function Index (FSFI) ranges from a minimum of 2.0 to a maximum of 36.0
Measured: 4 months post-baseline (follow-up 1)
Change in Female Sexual Functioning Index (FSFI) Total Score for Women From Baseline to Follow-up 2
The FSFI is a brief, self-report measure of female sexual function. The 19 items use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual function. The total score for the Female Sexual Function Index (FSFI) ranges from a minimum of 2.0 to a maximum of 36.0
Measured: 8 months post-baseline (follow up 2)
Changes International Index of Erectile Function (IIEF) for Men From Baseline to Follow up 1
The IIEF is a 15-item questionnaire designed to assess erectile functioning. Scores of 0 to 5 are awarded to each of the 15 questions. The five domains assessed include Erectile Function (Max score 30), Orgasmic Function (Max score 10), Sexual Desire (Max score 10), Intercourse Satisfaction (Max score 15) and Overall Satisfaction (Max score 10). Overall Scoring: 1-10: Severe Erectile Dysfunction, 11-16: Moderate dysfunction,17-21: Mild to moderate dysfunction, 22-25: Mild dysfunction, 26-30: No dysfunction. Higher scores indicate better sexual function/better outcome.
Measured: 4 months post-baseline (follow up 1)
Changes in International Index of Erectile Function (IIEF) for Men From Baseline to Follow up 2
The IIEF is a 15-item questionnaire designed to assess erectile functioning. Scores of 0 to 5 are awarded to each of the 15 questions. The five domains assessed include Erectile Function (Max score 30), Orgasmic Function (Max score 10), Sexual Desire (Max score 10), Intercourse Satisfaction (Max score 15) and Overall Satisfaction (Max score 10). Overall Scoring: 1-10: Severe Erectile Dysfunction, 11-16: Moderate dysfunction,17-21: Mild to moderate dysfunction, 22-25: Mild dysfunction, 26-30: No dysfunction. Higher scores indicate better sexual function/better outcome.
Measured: 8 months post-baseline (follow-up 2)
Secondary outcomes (8)
Change in Impact of Events Scale-Revised (IES-R) Total Score for Women and Men From Baseline to Follow up 1
The IES-R is a self-report measure designed to assess current subjective distress for any specific life event. Respondents rate each item in the IES-R on a scale of 0 (not at all), 1 (a little bit), 2 (moderately), 3 (quite a bit) and 4 (extremely) according to the past 7 days with regard to cancer and its treatment. the total score for the IES-R assessment can range from 0-88. In general, the higher the score, the more severely a person's life is disrupted by a traumatic event.
Measured: 4 months post-baseline (follow up 1)
Change in Impact of Events Scale-Revised (IES-R) Total Score for Women and Men From Baseline to Follow up 2
The IES-R is a self-report measure designed to assess current subjective distress for any specific life event. Respondents rate each item in the IES-R on a scale of 0 (not at all), 1 (a little bit), 2 (moderately), 3 (quite a bit) and 4 (extremely) according to the past 7 days with regard to cancer and its treatment. the total score for the IES-R assessment can range from 0-88. In general, the higher the score, the more severely a person's life is disrupted by a traumatic event.
Measured: 8 months post-baseline (follow up 2)
Changes in Depression and Anxiety Symptom Dimension Scores of Brief Symptom Inventory (BSI) for Women From Baseline to Follow up 1
The BSI (Brief Symptom Inventory) consists of 53 items. Participants rate the extent to which they have been bothered (0 ="not at all" to 4="extremely") in the past week by various symptoms. Higher scores indicate greater emotional distress. The BSI uses a 5-point Likert scale (0 = Not at all, 4 = Extremely), with rankings characterizing the intensity of distress during the past seven days. Scores are calculated as follows: Sum the item scores and divide by the number of items to obtain the mean score. Higher scores indicate greater emotional distress.
Measured: 4 months post-baseline (follow up 1)
Changes in Depression and Anxiety Symptom Dimension Scores of Brief Symptom Inventory (BSI) for Women From Baseline to Follow up 2
The BSI (Brief Symptom Inventory) consists of 53 items. Participants rate the extent to which they have been bothered (0 ="not at all" to 4="extremely") in the past week by various symptoms. Higher scores indicate greater emotional distress. The BSI uses a 5-point Likert scale (0 = Not at all, 4 = Extremely), with rankings characterizing the intensity of distress during the past seven days. Scores are calculated as follows: Sum the item scores and divide by the number of items to obtain the mean score. Higher scores indicate greater emotional distress.
Measured: 8 months post-baseline (follow up 2)
Change in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Total Score for Women From Baseline to Follow up 1
EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire ) is a well-validated instrument that assesses health-related quality of life in cancer patients. It is composed of 30-items, which factor into scales that evaluate physical functioning and role functioning, as well as emotional, social, and cognitive functioning and global QOL. Three symptom scales measure fatigue, pain, and emesis, while six single items assess financial impact, dyspnea, sleep disturbance, appetite, diarrhea, and constipation. The EORTC QLQ-C30 Summary Score is calculated from the mean of 13 of the 15 QLQ-C30 scales (the Global Quality of Life scale and the Financial Impact scale are not included). All of the scales and measures range in score from 0 to 100. A high scale score represents a higher response level/better outcome.
Measured: 4 months post-baseline (follow up 1)
Change in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Total Score for Women From Baseline to Follow up 2
EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire ) is a well-validated instrument that assesses health-related quality of life in cancer patients. It is composed of 30-items, which factor into scales that evaluate physical functioning and role functioning, as well as emotional, social, and cognitive functioning and global QOL. Three symptom scales measure fatigue, pain, and emesis, while six single items assess financial impact, dyspnea, sleep disturbance, appetite, diarrhea, and constipation. The EORTC QLQ-C30 Summary Score is calculated from the mean of 13 of the 15 QLQ-C30 scales (the Global Quality of Life scale and the Financial Impact scale are not included). All of the scales and measures range in score from 0 to 100. A high scale score represents a higher response level/better outcome.
Measured: 8 months post-baseline (follow up 2)
Change in Male-specific Variables (SEAR and Sexual Bother Subscale of the PHR-QOL) for Men From Baseline to Follow up 1
The Sexual Self-Esteem and Relationship Questionnaire (SEAR) is a 14-item measure that assesses sexual relationship satisfaction, sexual self-esteem, and overall relationship satisfaction. This measure was developed for use in men with ED. The items are scored on a 5-point Likert scale with higher scores indicating higher sexual satisfaction and sexual self-esteem. Higher scores indicated a more favorable response (0 = least favorable, 100 = most favorable). The Sexual Bother (SB) subscale of the Prostate-Health Related QOL (PHR-QOL) questionnaire is a 4-question scale that assesses men on a 5-point Likert scale (0-20). The four questions assess how sexual function has impacted close relationships, how big a problem it has been, if the patients have felt ashamed or embarrassed by their sexual function, and if it has impacted their ability to enjoy life. Higher scores indicate better outcomes (better functioning; less bother).
Measured: 4 months post-baseline (follow up 1)
Change in Male-specific Variables (SEAR and Sexual Bother Subscale of the PHR-QOL) for Men From Baseline to Follow up 2
The Sexual Self-Esteem and Relationship Questionnaire (SEAR) is a 14-item measure that assesses sexual relationship satisfaction, sexual self-esteem, and overall relationship satisfaction. This measure was developed for use in men with ED. The items are scored on a 5-point Likert scale with higher scores indicating higher sexual satisfaction and sexual self-esteem. Higher scores indicated a more favorable response (0 = least favorable, 100 = most favorable). The Sexual Bother (SB) subscale of the Prostate-Health Related QOL (PHR-QOL) questionnaire is a 4-question scale that assesses men on a 5-point Likert scale (0-20). The four questions assess how sexual function has impacted close relationships, how big a problem it has been, if the patients have felt ashamed or embarrassed by their sexual function, and if it has impacted their ability to enjoy life. Higher scores indicate better outcomes (better functioning; less bother).
Measured: 8 months post-baseline (follow up 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2008 (estimated)
- Study start24 Jun 2008
- Primary completion21 Nov 2024
- Study completion21 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Albert Einstein College of Medicine, Icahn School of Medicine at Mount Sinai, M.D. Anderson Cancer Center, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Christian Nelson, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712751
- Sponsor's protocol ID
- 08-073
- Status last verified
- Nov 2024
- First submitted
- 7 Jul 2008
- Last updated
- 26 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Nelson CJ, Schuler TA, Reiner AS, Baser RE, Demirjian CC, Mulhall J, Temple L, Schover L, Jandorf L, DuHamel KN. A psychoeducational intervention to improve sexual functioning in male rectal and anal cancer patients: A pilot randomized controlled trial study. Palliat Support Care. 2024 Feb 23:1-9. doi: 10.1017/S1478951523001906. Online ahead of print.
PubMed 38389458
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sexual Health of Rectal Cancer Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT00712751
- Acronym / sponsor ID
- 08-073
- Conditions
- Rectal Cancer, Rectum
- Keywords
- Rectum, Quality of Life, Sexual Health, 08-073
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Albert Einstein College of Medicine, Icahn School of Medicine at Mount Sinai, M.D. Anderson Cancer Center, National Institutes of Health (NIH)
- Study start
- 24 Jun 2008 (actual)
- Primary completion
- 21 Nov 2024 (actual)
- Study completion
- 21 Nov 2024 (actual)
- First posted
- 10 Jul 2008 (estimated)
- Results
- Posted 26 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We know that treatment for rectal, colorectal or anal cancer can impact sexual function. This study aims to learn:
- How the treatment affects emotional and social well-being.
- How a new sexual health educational program affects you.
Cancer patients seek education for lots of reasons. It often helps them cope because they can express their feelings with a trained professional. This study is open to individuals who have been treated for rectal, colorectal or anal cancer. It involves a new type of sexual health counseling program. It will teach participants skills that they can use to improve their sex lives. These skills may also improve physical and emotional well-being. We will compare the new type of sexual health program with the standard care patients receive after treatment for rectal, colorectal or anal cancer.
Detailed description
This is a two year randomized clinical trial examining the feasibility, tolerability, acceptability (including adherence) and efficacy of an intervention designed to improve sexual functioning of survivors of rectal cancer.
We have completed enrollment of female patients and are currently collecting follow up data. Recruitment for male patients is ongoing. Male participants will now be randomized in a 3:1 ratio to either the intervention condition (n = 40) or the control condition (n = 40).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: questionnairesusual care (UC) which is the standard care that patients receive |
| 2 | – | Behavioral: CSI-SH- Cancer Survivorship InterventionCancer Survivorship Intervention-Sexual Health (CSI-SH)plus Usual Care (US) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Colorectal patients
Key inclusion criteria (7 listed)
- At least six months post radiation and/or surgery for stage I-III rectal adenocarcinoma or rectosigmoid for cancer with an anastomosis at 15 cm or below and completed treatment
- At least six months post radiation and/or chemotherapy for anal cancer.
- Have no evidence of disease or recurrence
- For women indicate Indicate moderate satisfaction or below on their overall sexual life (a score of "4" or lower on the question "Over the past 4 weeks, how satisfied have you been with your overall sexual life?"
- For men indicate, and a score of "3" or lower on the question "How would you rate your confidence that you could get and keep an erection" for men) and a score of "2" or higher on the question "How much does this problem bother you?
Key exclusion criteria (3 listed)
- Significant cognitive or psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in a psychotherapeutic intervention.
- Are actively participating in protocol 06-151
- Participated in focus group or qualitative interview.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairesParticipants randomized to the Usual Care arm will receive standard care . For women, this is defined as the care that participants who are not in the intervention receive; we will ask these participants what psychosocial care they are receiving to track usual care. For men, "usual care" will consist of a standardized referral to the men's Sexual Medicine Program at MSKCC and written information in the form of the American Cancer Society (ACS) booklet on Sexuality after Cancer. Individuals randomized to Usual Care will not receive any additional counseling sessions from the study interventionists until they are done with the follow up interviews and then it will be offered to them. Follow up questionnaires will assess all study participants at 4 and 8 months after baseline. | Behavioural | 1 |
| CSI-SH- Cancer Survivorship InterventionThis involves four 1-hour individual sessions with three additional telephone booster/review sessions provided in between the four sessions. Sessions can be completed in person or conducted over the phone. Although every effort will be made to complete the booster session in between counseling sessions, if the patient is unavailable to complete the booster calls they may be skipped. Sessions one and two will focus on rehabilitation techniques and tools will be provided and discussed with participants during these first two sessions. | Behavioural | 2 |
Primary outcome
Change in Female Sexual Functioning Index (FSFI) Total Score for Women From Baseline to Follow-up 1
Time frame: 4 months post-baseline (follow-up 1)
The FSFI (Female Sexual Functioning Index) is a brief, self-report measure of female sexual function. The 19 items use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual function. The total score for the Female Sexual Function Index (FSFI) ranges from a minimum of 2.0 to a maximum of 36.0
Change in Female Sexual Functioning Index (FSFI) Total Score for Women From Baseline to Follow-up 2
Time frame: 8 months post-baseline (follow up 2)
The FSFI is a brief, self-report measure of female sexual function. The 19 items use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual function. The total score for the Female Sexual Function Index (FSFI) ranges from a minimum of 2.0 to a maximum of 36.0
Changes International Index of Erectile Function (IIEF) for Men From Baseline to Follow up 1
Time frame: 4 months post-baseline (follow up 1)
The IIEF is a 15-item questionnaire designed to assess erectile functioning. Scores of 0 to 5 are awarded to each of the 15 questions. The five domains assessed include Erectile Function (Max score 30), Orgasmic Function (Max score 10), Sexual Desire (Max score 10), Intercourse Satisfaction (Max score 15) and Overall Satisfaction (Max score 10). Overall Scoring: 1-10: Severe Erectile Dysfunction, 11-16: Moderate dysfunction,17-21: Mild to moderate dysfunction, 22-25: Mild dysfunction, 26-30: No dysfunction. Higher scores indicate better sexual function/better outcome.
Changes in International Index of Erectile Function (IIEF) for Men From Baseline to Follow up 2
Time frame: 8 months post-baseline (follow-up 2)
The IIEF is a 15-item questionnaire designed to assess erectile functioning. Scores of 0 to 5 are awarded to each of the 15 questions. The five domains assessed include Erectile Function (Max score 30), Orgasmic Function (Max score 10), Sexual Desire (Max score 10), Intercourse Satisfaction (Max score 15) and Overall Satisfaction (Max score 10). Overall Scoring: 1-10: Severe Erectile Dysfunction, 11-16: Moderate dysfunction,17-21: Mild to moderate dysfunction, 22-25: Mild dysfunction, 26-30: No dysfunction. Higher scores indicate better sexual function/better outcome.
8 secondary outcomes
Change in Impact of Events Scale-Revised (IES-R) Total Score for Women and Men From Baseline to Follow up 1
Time frame: 4 months post-baseline (follow up 1)
Change in Impact of Events Scale-Revised (IES-R) Total Score for Women and Men From Baseline to Follow up 2
Time frame: 8 months post-baseline (follow up 2)
Changes in Depression and Anxiety Symptom Dimension Scores of Brief Symptom Inventory (BSI) for Women From Baseline to Follow up 1
Time frame: 4 months post-baseline (follow up 1)
Changes in Depression and Anxiety Symptom Dimension Scores of Brief Symptom Inventory (BSI) for Women From Baseline to Follow up 2
Time frame: 8 months post-baseline (follow up 2)
Change in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Total Score for Women From Baseline to Follow up 1
Time frame: 4 months post-baseline (follow up 1)
Change in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Total Score for Women From Baseline to Follow up 2
Time frame: 8 months post-baseline (follow up 2)
Change in Male-specific Variables (SEAR and Sexual Bother Subscale of the PHR-QOL) for Men From Baseline to Follow up 1
Time frame: 4 months post-baseline (follow up 1)
Change in Male-specific Variables (SEAR and Sexual Bother Subscale of the PHR-QOL) for Men From Baseline to Follow up 2
Time frame: 8 months post-baseline (follow up 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38389458Nelson CJ, Schuler TA, Reiner AS, Baser RE, Demirjian CC, Mulhall J, Temple L, Schover L, Jandorf L, DuHamel KN. A psychoeducational intervention to improve sexual functioning in male rectal and anal cancer patients: A pilot randomized controlled trial study. Palliat Support Care. 2024 Feb 23:1-9. doi: 10.1017/S1478951523001906. Online ahead of print.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Nelson, PhD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Rectum, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Female Sexual Functioning Index (FSFI) Total Score for Women From Baseline to Follow-up 1 (time frame: 4 months post-baseline (follow-up 1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00712751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.