Sexual DysfunctionNCT04221607
An Intimacy Intervention for Couples Completing Breast or Prostate Cancer
A study testing Sensate Focus exercise in people with Sexual Dysfunction and Breast Cancer, run by Brown University at 2 sites in United States.
Trial summary
This project seeks to help patients address and improve intimacy at the end of treatment for breast or prostate cancer. It is intended to address the needs of cancer survivors, broadly defined as paftients and their loved ones or caregivers facing a cancer diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sexual Dysfunction, Breast Cancer, Prostate Cancer
- What is being tested?
- Sensate Focus exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Dec 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years) with histologically proven breast or prostate cancer
- Ability to speak English or able to complete questionnaires with assistance required from an interpreter or family member.
- Completed curative intent treatment for cancer no more than 6 months prior to study enrollment. Treatment may have consisted of surgery, chemotherapy, and/or radiation therapy. Patients on extended adjuvant (maintenance) treatment will be allowed to enroll.
- In a stable non-married relationship or otherwise partnered or married.
- Partner willing to participate in study
Who cannot join
- history of significant psychiatric or other co-morbid disease, which the treating clinician believes prohibits the patient's ability to participate in the informed consent procedures
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rhode Island Hospital
Providence, Rhode Island, 02382
The Miriam Hospital
Providence, Rhode Island, 02903
About this study
This project seeks to help patients address and improve intimacy at the end of treatment for breast or prostate cancer. It is intended to address the needs of cancer survivors, broadly defined as paftients and their loved ones or caregivers facing a cancer diagnosis. While we know sexual health is impacted by the diagnosis and treatments for cancer, we also are increasingly aware that partners and spouses are also impacted by the experience. Yet, there are no evidence based interventions that focus on the couple's recovery after the initial cancer experience.
The objective of this study is to look at the impact of an intimacy intervention at the completion of cancer treatment for couples facing breast or prostate cancer. We will enroll patients and their intimate partners in this study in two phases. In the first phase, couples will receive sensate focus homework, explained to them at a standard survivorship care visit (SCV) by a study nurse practitioner (NP). The objective in the first phase is to see if this is something feasible by looking at how many use sensate focus homework in 6 weeks. If it is not feasible, we will rework the study based on what we learned. However, if it is feasible, we will reopen the study to a larger group and employ a random assignment to an SCV with or without sensate focus homework. This phase will give us evidence of efficacy that we will use to propose a larger randomized trial, potentially in the National Cancer Institute system.
Participants will be asked to answer questionnaires at baseline, 6 weeks, and then at 12 weeks during phase 2. Those who complete treatment at 12 weeks will be re-contacted 6 months after protocol enrollment for an optional end of treatment interview to assess what they thought of the intervention, including sensate focus homework itself and the timing.
Read the detailed description
The National Comprehensive Cancer Network (NCCN) identifies sexual dysfunction as a major issue facing cancer survivors (defined broadly as patients and their caregivers, starting at the point of the index cancer diagnosis). It is well known that a cancer diagnosis and treatment negatively impacts partner relationships and quality of life (QOL) (for both patient and partner). Despite this, only about a third of patients seek assistance, and the figures regarding assistance from caregivers is lacking.
The etiology of sexual dysfunction is multifactorial and includes problems with sexual desire and pleasure, hormonal deficiencies, vaginal and penile alterations related to treatment, delayed or absent orgasm and/or ejaculation, pain with intercourse, erectile dysfunction, and psychological problems such as anxiety, depression, and changes in body-image. Unfortunately, interventions have largely focused on ways to improve sexual function, although even these are limited. Additionally, clinicians are often reluctant to address sexual function with their patients due to their lack of training and discomfort in engaging in these conversations. Given the well-documented burden of sexual dysfunction, there is a compelling need to develop interventions to address sexual health, for both patient and partner while encouraging clinicians to discuss sexual health issues.
Beyond the issues of the individual, couples and families are also impacted by cancer treatment. A wide body of literature shows that a cancer experience can add additional demands on couples, especially in the realms of communication, intimacy, and sexuality. A small study of 8 couples where the female partner had breast cancer identified three themes of significance: (1) disconnection from the relationship, due to the woman prioritizing her own needs before those of the partner or of them as a couple; (2) renegotiation of the couple relationship; and (3) need for support for negotiating going forward as a couple. Unfortunately, they also comment on the limited evidence-based interventions to aide this transition, particularly for the couple.
In this project, the investigators will build upon standard procedures to address intimacy at the end of curative intent therapy through sensate focusing exercises (SF). SF will be delivered during a face-to-face survivorship visit using a trial-specific script.
The project will proceed in two phases. During phase 1, the investigators will assess feasibility by conducting a prospective pilot study. During phase 2, the investigators will conduct a randomized trial comparing survivorship care with or without sensate focusing.
This project has the potential to substantially enhance the care of survivors. By implementing such an intervention to improve sexual function, we aim to enhance the QOL and intimacy of cancer survivors.
- Conditions
- Sexual Dysfunction, Breast Cancer, Prostate Cancer
- Being tested
- Sensate Focus exercise
- Keywords
- intimacy, sensate focus, survivorship, breast cancer, prostate cancer
- Medical subject headings
- Sexual Dysfunction, Physiological, Breast Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensate Focus exerciseOther
Structured exercise to enhance intimacy
| Study group | Role | What they receive |
|---|---|---|
| Feasibility | Experimental | Sensate Focus Exercises aim to help couples be more present with one another through talking and through touch. Receives: Other: Sensate Focus exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase one: Feasibility
Proportion of couples enrolled in phase one who are practicing sensate focus at 4 weeks
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start9 Dec 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility of intervention
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Keitner/Family Therapy Research Grant
- Responsible party
- Principal investigator, Don Dizon, Brown University
- Investigators
- Don S Dizon, MD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221607
- Sponsor's protocol ID
- 1413727
- Status last verified
- Apr 2021
- First submitted
- 4 Jan 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intimacy Intervention for Couples Completing Breast or Prostate Cancer
- ClinicalTrials.gov ID
- NCT04221607
- Acronym / sponsor ID
- 1413727
- Conditions
- Sexual Dysfunction, Breast Cancer, Prostate Cancer
- Keywords
- intimacy, sensate focus, survivorship, breast cancer, prostate cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Keitner/Family Therapy Research Grant
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 9 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project seeks to help patients address and improve intimacy at the end of treatment for breast or prostate cancer. It is intended to address the needs of cancer survivors, broadly defined as paftients and their loved ones or caregivers facing a cancer diagnosis. While we know sexual health is impacted by the diagnosis and treatments for cancer, we also are increasingly aware that partners and spouses are also impacted by the experience. Yet, there are no evidence based interventions that focus on the couple's recovery after the initial cancer experience.
The objective of this study is to look at the impact of an intimacy intervention at the completion of cancer treatment for couples facing breast or prostate cancer. We will enroll patients and their intimate partners in this study in two phases. In the first phase, couples will receive sensate focus homework, explained to them at a standard survivorship care visit (SCV) by a study nurse practitioner (NP). The objective in the first phase is to see if this is something feasible by looking at how many use sensate focus homework in 6 weeks. If it is not feasible, we will rework the study based on what we learned. However, if it is feasible, we will reopen the study to a larger group and employ a random assignment to an SCV with or without sensate focus homework. This phase will give us evidence of efficacy that we will use to propose a larger randomized trial, potentially in the National Cancer Institute system.
Participants will be asked to answer questionnaires at baseline, 6 weeks, and then at 12 weeks during phase 2. Those who complete treatment at 12 weeks will be re-contacted 6 months after protocol enrollment for an optional end of treatment interview to assess what they thought of the intervention, including sensate focus homework itself and the timing.
Detailed description
The National Comprehensive Cancer Network (NCCN) identifies sexual dysfunction as a major issue facing cancer survivors (defined broadly as patients and their caregivers, starting at the point of the index cancer diagnosis). It is well known that a cancer diagnosis and treatment negatively impacts partner relationships and quality of life (QOL) (for both patient and partner). Despite this, only about a third of patients seek assistance, and the figures regarding assistance from caregivers is lacking.
The etiology of sexual dysfunction is multifactorial and includes problems with sexual desire and pleasure, hormonal deficiencies, vaginal and penile alterations related to treatment, delayed or absent orgasm and/or ejaculation, pain with intercourse, erectile dysfunction, and psychological problems such as anxiety, depression, and changes in body-image. Unfortunately, interventions have largely focused on ways to improve sexual function, although even these are limited. Additionally, clinicians are often reluctant to address sexual function with their patients due to their lack of training and discomfort in engaging in these conversations. Given the well-documented burden of sexual dysfunction, there is a compelling need to develop interventions to address sexual health, for both patient and partner while encouraging clinicians to discuss sexual health issues.
Beyond the issues of the individual, couples and families are also impacted by cancer treatment. A wide body of literature shows that a cancer experience can add additional demands on couples, especially in the realms of communication, intimacy, and sexuality. A small study of 8 couples where the female partner had breast cancer identified three themes of significance: (1) disconnection from the relationship, due to the woman prioritizing her own needs before those of the partner or of them as a couple; (2) renegotiation of the couple relationship; and (3) need for support for negotiating going forward as a couple. Unfortunately, they also comment on the limited evidence-based interventions to aide this transition, particularly for the couple.
In this project, the investigators will build upon standard procedures to address intimacy at the end of curative intent therapy through sensate focusing exercises (SF). SF will be delivered during a face-to-face survivorship visit using a trial-specific script.
The project will proceed in two phases. During phase 1, the investigators will assess feasibility by conducting a prospective pilot study. During phase 2, the investigators will conduct a randomized trial comparing survivorship care with or without sensate focusing.
This project has the potential to substantially enhance the care of survivors. By implementing such an intervention to improve sexual function, we aim to enhance the QOL and intimacy of cancer survivors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility of intervention
| Arm | Type | Receives |
|---|---|---|
| Feasibility | Experimental | Other: Sensate Focus exerciseSensate Focus Exercises aim to help couples be more present with one another through talking and through touch. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (≥18 years) with histologically proven breast or prostate cancer
- Ability to speak English or able to complete questionnaires with assistance required from an interpreter or family member.
- Completed curative intent treatment for cancer no more than 6 months prior to study enrollment. Treatment may have consisted of surgery, chemotherapy, and/or radiation therapy. Patients on extended adjuvant (maintenance) treatment will be allowed to enroll.
- In a stable non-married relationship or otherwise partnered or married.
- Partner willing to participate in study
Key exclusion criteria (1 listed)
- history of significant psychiatric or other co-morbid disease, which the treating clinician believes prohibits the patient's ability to participate in the informed consent procedures
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 |
|---|---|---|
| Sensate Focus exerciseStructured exercise to enhance intimacy | Other | Feasibility |
Primary outcome
Phase one: Feasibility
Time frame: Four weeks
Proportion of couples enrolled in phase one who are practicing sensate focus at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Don S Dizon, MD principal investigator
Rhode Island Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensate Focus exercise in people with Sexual Dysfunction and Breast Cancer, run by Brown University 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 5 inclusion and 1 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 8 Apr 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Phase one: Feasibility (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2021.