Gender Related Coping and Survivorship for Genitourinary Cancers
Study Details
Study Description
Brief Summary
This research is being done to learn more about coping and survivorship of women with bladder cancer, specifically regarding psychosocial distress and sexual dysfunction. This study is a non-therapeutic study and will randomize participants to a standard of care group and education group. Patients in both groups will be asked to complete surveys regarding their mood and sexual function. Patients in the intervention group will be asked to complete attendance diaries regarding educational and support services utilized. Participants' clinical data will also be collected.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The Gender Related Coping and Survivorship Study for Genitourinary Cancers is focused on providing patients with additional education to promote sexual function in female bladder cancer patients with the aim to help decrease demoralization and sexual dysfunction. Patients receiving a cystectomy and patients not receiving a cystectomy will be randomized separately into an additional education or standard of care group. The additional education consists of asking patients to attend the Women and Bladder Cancer Educational Series, Women's Bladder Cancer Support Group meetings, referrals to other support services, receiving supplemental handouts and treating physician led counseling incorporated into standard of care visits. All participants will be asked to complete the Demoralization Scale-II and Female Sexual Function Index at baseline, one-month following treatment, three-months following treatment, six-months following treatment, and one year following treatment. Patients randomized to the additional education group will also be asked to complete an attendance diary one-month following treatment, three-months following treatment, six-months following treatment, and one year following treatment.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients not receiving a cystectomy - Standard of Care Group Patients will receive standard of care treatment. Patients will be asked to complete the Demoralization Scale II and Female Sexual Function Index at baseline, 3-months following treatment, 6-months following treatment, and one-year following treatment. |
Other: Questionnaires
Female Sexual Function Index, Demoralization Scale-II
|
| Patients not receiving a cystectomy - Additional Education Group Patients will receive additional education with standard of care treatment. Patients will be asked to complete the Demoralization Scale II and Female Sexual Function Index at baseline, 3-months following treatment, 6-months following treatment, and one-year following treatment. Patients will also be asked to complete an attendance diary documenting additional support services utilized. The Attendance Diary will be completed at 3-months following treatment, 6-months following treatment, and one-year following treatment. |
Other: Additional Education
Study-Specific Patient Handouts, Treating-Provider led counseling, Women's Bladder Cancer Support Group, Women's Bladder Cancer Educational Series, and referrals for additional support services
Other: Attendance Diary
Attendance Diaries for the Women's Bladder Cancer Support Group, Women's Bladder Cancer Educational Series, and additional educational and support services utilized
|
| Patients receiving a cystectomy- Standard of Care Group Patients will receive standard of care treatment. Patients will be asked to complete the Demoralization Scale II and Female Sexual Function Index at baseline, 3-months following treatment, 6-months following treatment, and one-year following treatment. |
Other: Questionnaires
Female Sexual Function Index, Demoralization Scale-II
|
| Patients receiving a cystectomy - Additional Education Group Patients will receive additional education with standard of care treatment. Patients will be asked to complete the Demoralization Scale II and Female Sexual Function Index at baseline, 3-months following treatment, 6-months following treatment, and one-year following treatment. Patients will also be asked to complete an attendance diary documenting additional support services utilized. The Attendance Diary will be completed at 3-months following treatment, 6-months following treatment, and one-year following treatment. |
Other: Additional Education
Study-Specific Patient Handouts, Treating-Provider led counseling, Women's Bladder Cancer Support Group, Women's Bladder Cancer Educational Series, and referrals for additional support services
Other: Attendance Diary
Attendance Diaries for the Women's Bladder Cancer Support Group, Women's Bladder Cancer Educational Series, and additional educational and support services utilized
|
Outcome Measures
Primary Outcome Measures
- Use Demoralization Scale-II to assess change in demoralization [Baseline, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment]
Evaluate educational interventions to improve demoralization in females with bladder cancer
Secondary Outcome Measures
- Use Female Sexual Function Index to assess change in sexual function [Baseline, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment]
Evaluate if educational interventions improve sexual function in females with bladder cancer.
- Change in coping as assessed by Demoralization Scale II [Baseline, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment]
Assess how coping in females with bladder cancer differs by stage of bladder cancer.
- Change in coping as assessed by the Female Sexual Function Index [Baseline, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment]
Assess how coping in females with bladder cancer differs by stage of bladder cancer.
- Survivorship [Baseline, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment]
Assess survivorship in females with bladder cancer differs by stage of bladder cancer.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Females with bladder cancer
-
Willing to answer surveys regarding their psychosocial health and sexual health
Exclusion Criteria:
-
Not undergoing either active treatment or active surveillance (i.e. patients on hospice care)
-
Patients with cognitive impairments
-
Women who are pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sibley Memorial Hospital | Washington | District of Columbia | United States | 20016 |
| 2 | Johns Hopkins Hospital | Baltimore | Maryland | United States | 21287 |
Sponsors and Collaborators
- Johns Hopkins University
Investigators
- Principal Investigator: Armine Smith, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00314755