Condition or disease | Intervention/treatment | Phase |
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Breast Cancer | Behavioral: Intimacy Enhancement Behavioral: Living Healthy Together | Not Applicable |
Over half of breast cancer survivors experience sexual concerns resulting from physical changes due to breast surgery, chemotherapy, and hormonal therapies; emotional changes; and relationship difficulties. In contrast with many aspects of quality of life (QOL) that tend to improve over time for breast cancer survivors, sexual concerns often persist for years. As a result, many breast cancer survivors and their partners may wish to resume a satisfying intimate relationship after treatment ends but encounter difficulties in doing so. Sexual concerns often go unaddressed, can lead to clinically significant psychological distress, and have a negative impact on survivors' relationships and quality of life. Thus, addressing sexual concerns and improving sexual function is of critical importance to the long-term adjustment of these survivors. Given the central role of the intimate relationship in breast cancer survivors' sexual experiences, a couple-based intervention that systematically involves the partner may be a highly effective approach for addressing these concerns and improving function. Yet randomized controlled trials evaluating the efficacy of a couple-based intervention targeting sexual function for breast cancer survivors are lacking. In this study, the investigators plan to evaluate a four-session telephone couple-based intervention that provides education and training in cognitive and behavioral skills to help couples cope with sexual concerns and enhance their intimate relationship, called Intimacy Enhancement (IE).
The specific aims of this study are (1) to evaluate whether the IE intervention will lead to a significantly greater increase in patient sexual function from pre-treatment to post-treatment and 3- and 6-month follow-ups compared to the LHT condition; (2) to evaluate whether the IE intervention will lead to significantly greater improvements in partner sexual function, patient sexual distress, patient/partner relationship intimacy/quality, and psychological distress from pre-treatment to post-treatment and at 3- and 6-month follow-ups, compared to the LHT condition; (3) to evaluate whether increases from pre- to post-treatment in patient sexual communication and self-efficacy for coping with sexual concerns mediate the beneficial effects of the IE intervention on patient sexual function at 3- and 6-month follow-ups.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Addressing Sexual Concerns in Breast Cancer Survivors: Randomized Controlled Trial of a Novel Couple-Based Intervention |
Actual Study Start Date : | May 24, 2019 |
Estimated Primary Completion Date : | February 1, 2023 |
Estimated Study Completion Date : | September 1, 2023 |
Arm | Intervention/treatment |
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Experimental: Intimacy Enhancement
Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy.
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Behavioral: Intimacy Enhancement
The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition.
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Active Comparator: Living Healthy Together
Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics.
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Behavioral: Living Healthy Together
The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jennifer Reese, PhD | 215-214-3223 | jennifer.reese@fccc.edu | |
Contact: Kristen Sorice, BA | 215-214-1433 | kristen.sorice@fccc.edu |
United States, Pennsylvania | |
Fox Chase Cancer Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19111 | |
Contact: Kristen Sorice, BA 215-214-1433 kristen.sorice@fccc.edu | |
Principal Investigator: Jennifer B Reese, PhD |
Tracking Information | |||||||||
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First Submitted Date ICMJE | April 24, 2019 | ||||||||
First Posted Date ICMJE | April 29, 2019 | ||||||||
Last Update Posted Date | July 29, 2020 | ||||||||
Actual Study Start Date ICMJE | May 24, 2019 | ||||||||
Estimated Primary Completion Date | February 1, 2023 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Change in Self-Reported Patient Sexual Function [ Time Frame: Baseline up to eight months ] Patients' self-reported sexual function will be measured using the 19-item Female Sexual Function Index (FSFI).Total scale scores range from 2 to 36, with higher scores indicating higher functioning. Mean change scores will be reported: positive mean change scores indicate increase in sexual functioning over time while negative mean change scores indicate decrease in sexual functioning over time.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Coping Together After Breast Cancer | ||||||||
Official Title ICMJE | Addressing Sexual Concerns in Breast Cancer Survivors: Randomized Controlled Trial of a Novel Couple-Based Intervention | ||||||||
Brief Summary | The objective of the proposed study is to evaluate an Intimacy Enhancement (IE) intervention in 120 female early stage breast cancer survivors reporting sexual concerns and their intimate partners. Couples will be randomized 1:1 to receive either the IE intervention or to an information and support condition (Living Healthy Together). The investigators will evaluate intervention effects on patient and partner sexual, relationship, and psychological outcomes. | ||||||||
Detailed Description |
Over half of breast cancer survivors experience sexual concerns resulting from physical changes due to breast surgery, chemotherapy, and hormonal therapies; emotional changes; and relationship difficulties. In contrast with many aspects of quality of life (QOL) that tend to improve over time for breast cancer survivors, sexual concerns often persist for years. As a result, many breast cancer survivors and their partners may wish to resume a satisfying intimate relationship after treatment ends but encounter difficulties in doing so. Sexual concerns often go unaddressed, can lead to clinically significant psychological distress, and have a negative impact on survivors' relationships and quality of life. Thus, addressing sexual concerns and improving sexual function is of critical importance to the long-term adjustment of these survivors. Given the central role of the intimate relationship in breast cancer survivors' sexual experiences, a couple-based intervention that systematically involves the partner may be a highly effective approach for addressing these concerns and improving function. Yet randomized controlled trials evaluating the efficacy of a couple-based intervention targeting sexual function for breast cancer survivors are lacking. In this study, the investigators plan to evaluate a four-session telephone couple-based intervention that provides education and training in cognitive and behavioral skills to help couples cope with sexual concerns and enhance their intimate relationship, called Intimacy Enhancement (IE). The specific aims of this study are (1) to evaluate whether the IE intervention will lead to a significantly greater increase in patient sexual function from pre-treatment to post-treatment and 3- and 6-month follow-ups compared to the LHT condition; (2) to evaluate whether the IE intervention will lead to significantly greater improvements in partner sexual function, patient sexual distress, patient/partner relationship intimacy/quality, and psychological distress from pre-treatment to post-treatment and at 3- and 6-month follow-ups, compared to the LHT condition; (3) to evaluate whether increases from pre- to post-treatment in patient sexual communication and self-efficacy for coping with sexual concerns mediate the beneficial effects of the IE intervention on patient sexual function at 3- and 6-month follow-ups. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE | Breast Cancer | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Reese JB, Zimmaro LA, Lepore SJ, Sorice KA, Handorf E, Daly MB, Schover LR, Kashy D, Westbrook K, Porter LS. Evaluating a couple-based intervention addressing sexual concerns for breast cancer survivors: study protocol for a randomized controlled trial. Trials. 2020 Feb 12;21(1):173. doi: 10.1186/s13063-019-3975-2. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
240 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | September 1, 2023 | ||||||||
Estimated Primary Completion Date | February 1, 2023 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03930797 | ||||||||
Other Study ID Numbers ICMJE | 18-1025 1R01CA222124-01A1 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Fox Chase Cancer Center | ||||||||
Study Sponsor ICMJE | Fox Chase Cancer Center | ||||||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Fox Chase Cancer Center | ||||||||
Verification Date | July 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |