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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA279278 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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SHAREonline is a study for young female cancer survivors that are experiencing changes in sexual health and function.
The purpose of this research is to compare two brief interventions delivered by videoconference to learn if they help women effectively manage these changes and restore sexual health and functioning.
The purpose of this research is to compare two brief interventions delivered by videoconference to learn if they help women effectively manage these changes and restore sexual health and functioning.
Participants in this study would first complete health questionnaires and then be randomized to take part in one of two types of education sessions delivered by an instructor over videoconference: 1) Group education session or 2) Individual self-management session.
About 56 women will receive the group education session and about 28 will receive the individual self-management session.
It is expected that about 84 women will take part in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHAREonline | Experimental | Participants will receive:
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| Individual Self Management | Active Comparator | Brief individualized session with online and written materials and guidance. All Participants will complete study questionnaires at baseline, 2 months and 4 months post intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group Session | Behavioral | On-line educational session-3 modules-1 hour each for a total of 3 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Sexual Function | The Female Sexual Function Index (FSFI Full Scale Score), is 19-item instrument which measures sexual function, including desire, orgasm, pain and satisfaction. | Baseline to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Emotional Distress | BSI-18 (Brief Symptom Inventory) The BSI-18 is a well-validated screening measure of psychological distress with subscales measuring anxiety, depression and somatization that is frequently used with oncology populations. | Baseline to 2 month |
| Change in Sexual Function |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual Self-efficacy | Sexual Self-Efficacy Scale is a 5-item scale developed to measure perceived sexual self-efficacy to address sexual health after cancer. | Baseline to 2 months |
| Sexual Self-efficacy |
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Bober, PhD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Coaching Call | Behavioral | Single Coaching phone call at one month |
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| Educational Materials | Behavioral | Individual videoconference session in which participants will receive a pdf of the American Cancer Society booklet, 'Sex and the Adult Female with Cancer |
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The Female Sexual Function Index (FSFI Full Scale Score), is 19-item instrument which measures sexual function, including desire, orgasm, pain and satisfaction. |
| Baseline to 4 months |
| Change in Emotional Distress | BSI-18 (Brief Symptom Inventory) The BSI-18 is a well-validated screening measure of psychological distress with subscales measuring anxiety, depression and somatization that is frequently used with oncology populations. | Baseline to 4 months |
| Enrollment Rate | Measured through study accrual with a benchmark of enrollment greater than or equal to 40% of eligible candidates | Baseline to 1 month |
| Intervention Acceptability Rate | Intervention Satisfaction Questionnaire will be assessed using a benchmark mean score of 4 | Up to 1 month-post intervention |
| Study Engagement Rate | Measured through study engagement with a benchmark of study engagement greater than or equal to 70% of eligible candidates | Baseline to 1 month |
| Intervention Completion Rate | Measured through intervention completion with a benchmark of intervention completion greater than or equal to 60% of eligible candidates | Baseline to 4 months |
| Distress about Sexual Function | Sexual Distress Scale-short form (SDS-SF) is a 5-item measure which assesses distress about sexual function. | Baseline to 2 months |
| Distress about Sexual Function | Sexual Distress Scale-short form (SDS-SF) is a 5-item measure which assesses distress about sexual function. | Baseline to 4 months |
| Sexual Function, Satisfaction and Sexual Inactivity | PROMIS Sexual Function and Satisfaction (PROMIS SexFS) is a short screening | Baseline to 2 months |
Sexual Self-Efficacy Scale is a 5-item scale developed to measure perceived sexual self-efficacy to address sexual health after cancer.
| Baseline to 4 months |
| Coaching Satisfaction Summary | Brief participant questionnaire to provide feedback about coaching session. | Up to 1 month post-coaching session |