Ignite Creation Date:
2024-05-06 @ 1:07 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03930797
Status:
COMPLETED
Last Update Posted:
2024-07-11
First Post:
2019-04-24
Brief Title:
Coping Together After Breast Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Addressing Sexual Concerns in Breast Cancer Survivors Randomized Controlled Trial of a Novel Couple-Based Intervention
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 240 total participants Couples will be randomized 11 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 patientpartner relationship intimacyquality 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
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 patientpartner relationship intimacyquality 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01CA222124-01A1 | NIH | None | httpsreporternihgovquickSearch1R01CA222124-01A1 |