- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02721147
Pilot Study of an Intimacy Enhancement Intervention for Couples Facing Breast Cancer
October 24, 2018 updated by: Fox Chase Cancer Center
The central goal of this study is to examine the feasibility, acceptability, and preliminary efficacy of the IE intervention on patient and partner sexual QOL and relationship outcomes, and on patient psychosocial outcomes.
We expect that the IE will show adequate feasibility, acceptability, and preliminary efficacy.
Secondarily, based on the rationale that barriers exist that limit participation in intensive sexual QOL interventions for breast cancer survivors, an innovative secondary aim will investigate the perspectives of study-eligible patient candidates who opt out of participating in the pilot trial.
We expect that we will be able to identify the participation barriers and intervention preferences of breast cancer survivors with sexual concerns who opt out of the intensive trial in order to inform the development of different interventions for future study.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
89
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female
- Age > 21 years
- Has diagnosis of non-recurrent stage I-III breast cancer
- Completed active treatment (e.g., chemotherapy, radiation therapy, surgery) 6 months-5 years ago (current use of endocrine therapy is acceptable)
- Has a partner or spouse who is > 21
- Lives with a romantic partner > 6 months
- Score of > 3 on Patient Care Monitor Sexual Concerns screening item
- No hearing impairment in patient or partner
Exclusion Criteria:
- Not able to speak English, as stated in medical record or as observed by study team member
- ECOG Performance score > 2 OR too ill to participate as judged by physician/in medical record
- Overt cognitive dysfunction or psychiatric disturbance such as suicidal ideation or severe mental illness, as observed or judged by the researcher, referring source, or other qualified observer.
- Past history of any cancer other than non-melanoma skin cancer
- Currently participating in couple/marital therapy
- Currently pregnant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intimacy Enhancing Intervention
Participants attend 4 intimacy enhancement intervention sessions over 75 minutes every other week for 4 weeks.
The intimacy enhancement intervention comprises 4 main sessions: understanding impact of breast cancer on sex and intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges.
Participants are encouraged to participate in written and behavioral activities at home.
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Participants attend 4 intimacy enhancement intervention sessions over 75 minutes every other week for 4 weeks.
The intimacy enhancement intervention comprises 4 main sessions: understanding impact of breast cancer on sex and intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges.
Participants are encouraged to participate in written and behavioral activities at home.
Receive couple-based intimacy enhancement intervention
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Active Comparator: Living Healthy Together
Participants receive educational information and support about breast cancer every other week for 4 weeks.
The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet.
Participants are encouraged to read educational materials.
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Participants receive educational information and support about breast cancer every other week for 4 weeks.
The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet.
Participants are encouraged to read educational materials.
Receive educational information and support
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of the Treatment as Measured Through Study Accrual
Time Frame: Up to 8 weeks
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Feasibility is measured through the percentage of study eligible individuals who enrolled in the intervention study (i.e., acceptance rate).
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Up to 8 weeks
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Feasibility of the Treatment as Measured Through Study Attrition
Time Frame: Up to 8 weeks
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Feasibility of treatment is measured through the number of randomized participants who completed the study.
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Up to 8 weeks
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Feasibility of the Treatment as Measured Through Session Completion by Participant
Time Frame: Up to 8 weeks
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Feasibility of the treatment as measured through number of randomized participants who completed all 4 telephone sessions.
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Up to 8 weeks
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Acceptability Measured Using the Client Satisfaction Questionnaire (CSQ-8)
Time Frame: Up to 8 weeks
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Acceptability was measured through the median score on a validated acceptability measure.
Item responses run on a scale of 1 to 4, with a total score range of 8-32.
Higher scores indicate higher satisfaction with the service (acceptability).
A median score of 28 or higher is considered acceptable.
This measure was collected for both patients and partners.
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Up to 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Sexual Function Measured Using the Female Sexual Function Index (FSFI)
Time Frame: Baseline to up to 8 weeks
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Total scale scores range from 2 to 36.
Higher scores indicate higher level of functioning.
Change in mean patient FSFI score from pre-intervention to post-intervention is reported.
Positive mean change scores indicate increase in sexual functioning from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Sexual Function Measured Using the International Index of Erectile Function
Time Frame: Baseline to up to 8 weeks
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Total scale scores range from 1 to 75, with higher scores indicating a higher level of sexual functioning.
Change in mean male partner IIEF score from pre-intervention to post-intervention is reported.
Positive mean change scores indicate increase in sexual functioning from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Sexual Satisfaction Measured Using the Patient-Reported-Outcomes Measurement Information System (PROMIS) Sexual Satisfaction Items
Time Frame: Baseline to up to 8 weeks
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The PROMIS uses T-scores that are calculated against U.S. population norms with a M of 50 and SD of 10.
Higher T-scores indicate higher levels of sexual satisfaction.
Change in sexual satisfaction T-scores from pre-intervention to post-intervention are reported.
Positive change scores indicate increase in sexual satisfaction from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Sexual Distress Measured Using the Female Sexual Distress Scale-Revised
Time Frame: Baseline to up to 8 weeks
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Total scale scores range from 0 to 52.
Higher scores indicate higher levels of sexual distress.
Change in patient mean sexual distress score from pre-intervention to post-intervention is reported.
Negative mean change scores indicate decrease in sexual distress from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Beliefs (Self-efficacy)
Time Frame: Baseline to up to 8 weeks
|
Total scale scores range from 0 to 100.
Higher scores indicate higher degree of self-efficacy for coping with sexual concerns.
Change in mean self-efficacy score from pre-intervention to post-intervention is reported.
Positive mean change scores indicate increase in self-efficacy from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Emotional Intimacy Measured Using the Personal Assessment of Intimacy in Relationships (PAIR) Emotional Intimacy Scale
Time Frame: Baseline to up to 8 weeks
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Total scale scores range from 1 to 5. Higher scores indicate higher level of emotional intimacy with one's partner.
Change in mean emotional intimacy score from pre-intervention to post-intervention is reported.
Positive mean change scores indicate increase in emotional intimacy from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Sexual Communication Measured Using the Dyadic Sexual Communication Scale
Time Frame: Baseline to up to 8 weeks
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Total scale scores range from 13 to 78.
Higher scores indicate more communication.
Change in mean sexual communication score from pre-intervention to post-intervention is reported.
Positive mean change scores indicate increase in sexual communication from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Relationship Quality Measured Using the Dyadic Adjustment Scale-7 Item
Time Frame: Baseline to up to 8 weeks
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Total scale scores range from 0 to 36.
Higher scores indicate higher relationship quality.
Change in mean relationship quality score from pre-intervention to post-intervention is reported.
Positive mean change scores indicate increase in relationship quality from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Body Image Distress Measured Using the Body Image Scale
Time Frame: Baseline to up to 8 weeks
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Total scale scores range from 0 to 30.
Higher scores indicate higher level of body image distress.
Change in mean body image distress score from pre-intervention to post-intervention is reported.
Negative mean change scores indicate decrease in body image distress from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Depression Measured Using the Patient Health Questionnaire-9 Item
Time Frame: Baseline to up to 8 weeks
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Total scale scores range from 0 to 27.
Higher scores indicate higher level of depression.
Change in mean depression score from pre-intervention to post-intervention is reported.
Negative mean change scores indicate decrease in depression from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Anxiety Measured Using the Generalized Anxiety Disorder 7-item
Time Frame: Baseline to up to 8 weeks
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Total scale scores range from 0 to 21.
Higher scores indicate higher levels of anxiety.
Change in mean anxiety score from pre-intervention to post-intervention is reported.
Negative mean change scores indicate decrease in anxiety from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Cancer-related Distress Using the Impact of Events Scale-Revised
Time Frame: Baseline to up to 8 weeks
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Total scale scores range from 0 to 88.
Higher scores indicate higher levels of distress.
Change in mean cancer-related distress score from pre-intervention to post-intervention is reported.
Negative mean change scores indicate decrease in distress from pre- to post-intervention.
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Baseline to up to 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 27, 2015
Primary Completion (Actual)
September 29, 2017
Study Completion (Actual)
September 29, 2017
Study Registration Dates
First Submitted
March 14, 2016
First Submitted That Met QC Criteria
March 28, 2016
First Posted (Estimate)
March 29, 2016
Study Record Updates
Last Update Posted (Actual)
October 25, 2018
Last Update Submitted That Met QC Criteria
October 24, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-8007
- 1R21CA191354-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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