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Completed

NCT Number: NCT02721147

Pilot Study of an Intimacy Enhancement Intervention for Couples Facing Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intimacy Enhancing Intervention

Behavioral

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.

Living Healthy Together

Behavioral

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.

Partner-Assisted Coping Skills Training

Behavioral

Receive couple-based intimacy enhancement intervention

Behavioral, Psychological or Informational Intervention

Behavioral

Receive educational information and support

Primary outcomes

  1. Feasibility of the Treatment as Measured Through Study Accrual

    Time frame: Up to 8 weeks

    Feasibility is measured through the percentage of study eligible individuals who enrolled in the intervention study (i.e., acceptance rate).

  2. Feasibility of the Treatment as Measured Through Study Attrition

    Time frame: Up to 8 weeks

    Feasibility of treatment is measured through the number of randomized participants who completed the study.

  3. Feasibility of the Treatment as Measured Through Session Completion by Participant

    Time frame: Up to 8 weeks

    Feasibility of the treatment as measured through number of randomized participants who completed all 4 telephone sessions.

  4. Acceptability Measured Using the Client Satisfaction Questionnaire (CSQ-8)

    Time frame: Up to 8 weeks

    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.

Secondary outcomes

  1. Change in Sexual Function Measured Using the Female Sexual Function Index (FSFI)

    Time frame: Baseline to up to 8 weeks

    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.

  2. Change in Sexual Function Measured Using the International Index of Erectile Function

    Time frame: Baseline to up to 8 weeks

    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.

  3. 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

    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.

  4. Change in Sexual Distress Measured Using the Female Sexual Distress Scale-Revised

    Time frame: Baseline to up to 8 weeks

    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.

  5. 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.

  6. 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

    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.

  7. Change in Sexual Communication Measured Using the Dyadic Sexual Communication Scale

    Time frame: Baseline to up to 8 weeks

    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.

  8. Change in Relationship Quality Measured Using the Dyadic Adjustment Scale-7 Item

    Time frame: Baseline to up to 8 weeks

    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.

  9. Change in Body Image Distress Measured Using the Body Image Scale

    Time frame: Baseline to up to 8 weeks

    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.

  10. Change in Depression Measured Using the Patient Health Questionnaire-9 Item

    Time frame: Baseline to up to 8 weeks

    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.

  11. Change in Anxiety Measured Using the Generalized Anxiety Disorder 7-item

    Time frame: Baseline to up to 8 weeks

    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.

  12. Change in Cancer-related Distress Using the Impact of Events Scale-Revised

    Time frame: Baseline to up to 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 29, 2016
Registry last updated
Oct 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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