Prostate CancerNCT01982058
Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer
A study testing communication intervention, counseling intervention and nutrition intervention in people with Prostate Cancer and Sexual Dysfunction and Infertility, run by Rutgers, The State University of New Jersey at 6 sites in United States.
Trial summary
RATIONALE: Participating in a therapy program may enhance communication and intimacy between men with prostate cancer and their partners. PURPOSE: This randomized clinical trial is studying how well therapy enhances communication and intimacy for men with early stage prostate cancer and for their partners. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Sexual Dysfunction and Infertility, Sexuality
- What is being tested?
- communication intervention, counseling intervention and nutrition intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 483 participants
- Where
- 6 sitesUnited States
- Study dates
- 18 Aug 2011to 7 Aug 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient has a primary diagnosis of localized prostate cancer (T1, T2, N=0 M=0, T3 N=0 M=0)
- Patient had surgery or initiated radiation treatment (brachytherapy or external beam radiation) or began pre-radiation Androgen deprivation therapy within the past 12 months.
- Patient is currently married or living with a partner, with relationship duration at least 1 year
- Patient and partner live within a 1 hour commuting distance to recruitment site
- Patient and partner read and speak English
- Patient has an Impact of Events Scale (IES) score greater than or equal to 16 and/or partner has an IES score greater than or equal to 17.
Who cannot join
- Patient had a previous definitive treatment for prostate cancer
- Patient has a concurrent diagnosis of another cancer (other than non-melanoma skin cancer)
- Partner is diagnosed with cancer (other than non-melanoma skin cancer)
- Patient or partner have a significant hearing impairment
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Memorial Sloan-Kettering Cancer Center
New York, New York, 10022
The University Hospital
Newark, New Jersey, 07103
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Garden State Urology
Whippany, New Jersey, 07981
About this study
RATIONALE: Participating in a therapy program may enhance communication and intimacy between men with prostate cancer and their partners.
PURPOSE: This randomized clinical trial is studying how well therapy enhances communication and intimacy for men with early stage prostate cancer and for their partners.
Read the detailed description
Aim 1 A. To evaluate the impact of an Intimacy-Enhancing Couples' intervention (IEC) versus a General Health and Wellness Intervention (GHW) and a Usual care control (UC) on patient and partner psychological and relationship outcomes.
- To determine whether relationship length, pre-intervention relationship satisfaction, and men's pre-intervention masculinity moderate the effects of IEC on couples' psychological and relationship outcomes
Aim 2 A. To evaluate whether IEC has an effect on couples' communication and intimacy when compared with GHW and UC and to determine whether changes in relationship communication and intimacy mediate changes in couples' psychological and relationship outcomes.
Exploratory Aim:
- To evaluate the impact of IEC versus GHW on physical activity and fruit and vegetable intake as well as each partner's support for the other partner's adoption of greater physical activity and more fruit and vegetable intake.
- Being tested
- communication intervention, counseling intervention, nutrition intervention, questionnaire administration
- Medical subject headings
- Prostatic Neoplasms, Sexual Dysfunction, Physiological, Infertility, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
communication interventionOther
counseling interventionOther
nutrition interventionOther
questionnaire administrationOther
| Study group | Role | What they receive |
|---|---|---|
| Intimacy-Enhancing Couples | Experimental | Patients and their partners receive communication and intimacy-enhancing intervention (IEC) once a week comprising the following five 90-minute sessions: Orientation and Stories of the Cancer Experience; Communication and Listening to Partner's concerns; Communication and Coping with Cancer Issues as a Team; Being Supportive to Solve Concerns; and Reflecting on Changes and Future Adaptation. Receives: Other: communication intervention; Other: counseling intervention; Other: questionnaire administration |
| General Health and Wellness | Active comparator | Patients and their partners receive a General Health and Wellness intervention focusing on nutrition and physical activity once a week comprising of five 90-minute sessions: Introduction and Nutrition Basics; Nutrition and Prevention of Recurrence; Nutritional Review and Introduction to Relaxation; Physical Activity Basics; Aerobics and Resistance Exercises and Wrap up. Receives: Other: counseling intervention; Other: nutrition intervention; Other: questionnaire administration |
| Usual Care | Other | Patients and their partners receive standard psychological and emotional care (usual care [UC]) (i.e., social work consultations and referral to a psychiatrist or psychologist, if requested or deemed necessary by the attending physician). Receives: Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Functioning
General psychological functioning is assessed by the MHI-38 and the PHQ-9. Cancer-Specific distress is assessed by using the Impact of Events Scale Revised Cancer-Specific concerns is assessed with a 10 item assessment of commonly-experienced problems.
Measured: 5 years
Relationship Functioning
Relationship satisfaction is assessed using the Dyadic Adjustment Scale
Measured: 5 years
Secondary outcomes (2)
Intimacy
General Relationship Intimacy. The Personal Assessment of Intimacy in Relationships Intimacy scale (PAIR) (94) is a 6 item scale assessing emotional closeness. Cancer-specific Relationship Intimacy (95-96) Participants rate the degree to which they felt close to and emotionally intimate with their partner during discussions about the cancer experience.
Measured: 5 years
Relationship Communication
Perceived self-disclosure. The scale assesses the degree to which they disclose thoughts, information, and feelings about the cancer experience in the past week.
Perceived partner disclosure. The scale assesses the degree to which their partner disclosed thoughts, information, and feelings.
Perceived partner responsiveness. The scale assesses the degree to which the participant felt their partner understood and empathized with their disclosures.Mutual Constructive Communication. This subscale of the Communication Pattern Questionnaire (CPQ) is a 5-item scale that has been adapted.
Holding back. Participants rate the degree to which they held back from talking to their partner about 11 domains of concern.
Demand-Withdraw. The CPQ Demand-Withdraw subscale is a 6-item scale adapted.
Mutual Avoidance. The CPQ Mutual Avoidance subscale is an adapted 6-item scale.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study start18 Aug 2011
- Primary completion7 Aug 2017
- Study completion7 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 483 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers Cancer Institute of New Jersey, Memorial Sloan Kettering Cancer Center, Fox Chase Cancer Center
- Responsible party
- Principal investigator, Sharon Manne, PhD, Rutgers, The State University of New Jersey
- Investigators
- Sharon L Manne, Ph.D., Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982058
- Sponsor's protocol ID
- 0220100274
- Other IDs
- 0220100274, NCI-2012-00552, 131023
- Status last verified
- Oct 2022
- First submitted
- 24 Jun 2013
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT01982058
- Acronym / sponsor ID
- 0220100274
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 483 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Rutgers Cancer Institute of New Jersey, Memorial Sloan Kettering Cancer Center, Fox Chase Cancer Center
- Study start
- 18 Aug 2011 (actual)
- Primary completion
- 7 Aug 2017 (actual)
- Study completion
- 7 Aug 2017 (actual)
- First posted
- 13 Nov 2013 (estimated)
- 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.
RATIONALE: Participating in a therapy program may enhance communication and intimacy between men with prostate cancer and their partners.
PURPOSE: This randomized clinical trial is studying how well therapy enhances communication and intimacy for men with early stage prostate cancer and for their partners.
Detailed description
Aim 1 A. To evaluate the impact of an Intimacy-Enhancing Couples' intervention (IEC) versus a General Health and Wellness Intervention (GHW) and a Usual care control (UC) on patient and partner psychological and relationship outcomes.
- To determine whether relationship length, pre-intervention relationship satisfaction, and men's pre-intervention masculinity moderate the effects of IEC on couples' psychological and relationship outcomes
Aim 2 A. To evaluate whether IEC has an effect on couples' communication and intimacy when compared with GHW and UC and to determine whether changes in relationship communication and intimacy mediate changes in couples' psychological and relationship outcomes.
Exploratory Aim:
- To evaluate the impact of IEC versus GHW on physical activity and fruit and vegetable intake as well as each partner's support for the other partner's adoption of greater physical activity and more fruit and vegetable intake.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intimacy-Enhancing Couples | Experimental | Other: communication intervention, Other: counseling intervention, Other: questionnaire administrationPatients and their partners receive communication and intimacy-enhancing intervention (IEC) once a week comprising the following five 90-minute sessions: Orientation and Stories of the Cancer Experience; Communication and Listening to Partner's concerns; Communication and Coping with Cancer Issues as a Team; Being Supportive to Solve Concerns; and Reflecting on Changes and Future Adaptation. |
| General Health and Wellness | Active comparator | Other: counseling intervention, Other: nutrition intervention, Other: questionnaire administrationPatients and their partners receive a General Health and Wellness intervention focusing on nutrition and physical activity once a week comprising of five 90-minute sessions: Introduction and Nutrition Basics; Nutrition and Prevention of Recurrence; Nutritional Review and Introduction to Relaxation; Physical Activity Basics; Aerobics and Resistance Exercises and Wrap up. |
| Usual Care | Other | Other: questionnaire administrationPatients and their partners receive standard psychological and emotional care (usual care [UC]) (i.e., social work consultations and referral to a psychiatrist or psychologist, if requested or deemed necessary by the attending physician). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient has a primary diagnosis of localized prostate cancer (T1, T2, N=0 M=0, T3 N=0 M=0)
- Patient had surgery or initiated radiation treatment (brachytherapy or external beam radiation) or began pre-radiation Androgen deprivation therapy within the past 12 months.
- Patient is currently married or living with a partner, with relationship duration at least 1 year
- Patient and partner live within a 1 hour commuting distance to recruitment site
- Patient and partner read and speak English
Key exclusion criteria (4 listed)
- Patient had a previous definitive treatment for prostate cancer
- Patient has a concurrent diagnosis of another cancer (other than non-melanoma skin cancer)
- Partner is diagnosed with cancer (other than non-melanoma skin cancer)
- Patient or partner have a significant hearing impairment
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 |
|---|---|---|
| communication intervention | Other | Intimacy-Enhancing Couples |
| counseling intervention | Other | General Health and Wellness, Intimacy-Enhancing Couples |
| nutrition intervention | Other | General Health and Wellness |
| questionnaire administration | Other | General Health and Wellness, Intimacy-Enhancing Couples, Usual Care |
Primary outcome
Psychological Functioning
Time frame: 5 years
General psychological functioning is assessed by the MHI-38 and the PHQ-9. Cancer-Specific distress is assessed by using the Impact of Events Scale Revised Cancer-Specific concerns is assessed with a 10 item assessment of commonly-experienced problems.
Relationship Functioning
Time frame: 5 years
Relationship satisfaction is assessed using the Dyadic Adjustment Scale
2 secondary outcomes
Intimacy
Time frame: 5 years
Relationship Communication
Time frame: 5 years
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 19 Oct 2022.
- Individual participant dataSharing planned: No
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RecruitingPhase 2
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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.
Sharon L Manne, Ph.D. principal investigator
Rutgers Cancer Institute of New Jersey
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing communication intervention, counseling intervention and nutrition intervention in people with Prostate Cancer and Sexual Dysfunction and Infertility, run by Rutgers, The State University of New Jersey at 6 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 6 inclusion and 4 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 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Psychological Functioning (time frame: 5 years). The study lists 2 primary outcomes in all. 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 19 Oct 2022.