Clinical trial · Interventional
Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer
NCT01982058CI-TRIAL-00061541completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Sexual Dysfunction and Infertility | — | UNRESOLVED | — |
| Sexuality | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| communication intervention | Other | — | UNRESOLVED |
| counseling intervention | Other | — | UNRESOLVED |
| nutrition intervention | Other | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Intimacy-Enhancing Couples
- description
- 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.
- interventionNames
- Other: communication intervention
- Other: counseling intervention
- Other: questionnaire administration
- type
- ACTIVE_COMPARATOR
- label
- General Health and Wellness
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.