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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01357 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 21349 | Other Identifier | Stanford University |
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| Name | Class |
|---|---|
| California Breast Cancer Research Program | OTHER |
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This randomized phase I trial studies at-home group video calling sessions in quality of life in rural patients with breast cancer. At-home group video calling support sessions may improve the well-being and quality of life of women who have breast cancer
PRIMARY OBJECTIVES:
I. To examine whether delivering at-home professionally-led breast cancer support using group video calling is feasible, acceptable and satisfactory for women in rural northern California.
II. To evaluate the feasibility of using on-line tools to recruit, screen, treat, and assess this population for a subsequent randomized clinical trial.
III. Assess whether the rate of recruitment of women in this region in this study using predominantly on-line means of recruitment can be improved over that of the previous study using predominantly face-to-face means of recruitment.
SECONDARY OBJECTIVES:
I. Estimate effect size changes in measures of quality of life (post-traumatic stress disorder symptoms, depression symptoms, perceived stress, and positive states of mind), satisfaction with social support, and self-efficacy for coping with cancer.
II. Prescribe sample size. III. Perform I and II for all of these outcomes.
OUTLINE: Participants are randomized to 1 of 2 treatment arms.
ARM I (experimental arm): Participants complete at-home group video calling sessions for 1 1/2 hours once weekly for 8 weeks.
ARM II (control arm): Participants receive an educational workbook journal.
After completion of study treatment, participants are followed up for 1 week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (experimental arm) | Experimental | Participants complete at-home group video calling sessions for 1 1/2 hours once weekly for 8 weeks. |
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| Arm II (control arm) | Active Comparator | Participants receive an educational workbook journal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| support group therapy | Procedure | Complete at-home group video calling support sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the study protocol as determined primarily through qualitative analysis of the group sessions and the interview data | The major criterion for determining feasibility is to determine whether we can recruit rural women with breast cancer more rapidly using predominantly on-line procedures in this study than in our previous study that predominantly used face-to-face procedures. The qualitative data for determining the feasibility will be collected during the at-home group video calling sessions and from women's interviews conducted at the end of the study. Will be assessed using mixed methods. | At 1 week post-intervention |
| Acceptability of the study protocol as determined primarily through qualitative analysis of the group sessions and the interview data | The qualitative data for determining the acceptability will be collected during the at-home group video calling sessions and from women's interviews conducted at the end of the study. Will be assessed using mixed methods. | At 1 week post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in quality of life (posttraumatic stress, depression symptoms, perceived stress, and positive states of mind) | Treatment effect size will be estimated for each measure for the purpose of prescribing the sample size for a subsequent larger randomized clinical trial examining efficacy of the intervention. Will be analyzed using generalized linear mixed models. | From baseline to 1 week post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheryl Koopman | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sierra Streams Institute | Nevada City | California | 95959 | United States | ||
| Stanford University Cancer Institute |
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| educational intervention | Other | Receive an educational workbook journal |
|
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| Changes in satisfaction with social support | Treatment effect size will be estimated for each measure for the purpose of prescribing the sample size for a subsequent larger randomized clinical trial examining efficacy of the intervention. Will be analyzed using generalized linear mixed models. | From baseline to 1 week post-intervention |
| Changes in self-efficacy for coping with cancer | Treatment effect size will be estimated for each measure for the purpose of prescribing the sample size for a subsequent larger randomized clinical trial examining efficacy of the intervention. Will be analyzed using generalized linear mixed models. | From baseline to 1 week post-intervention |
| Stanford |
| California |
| 94305 |
| United States |
| ID | Term |
|---|---|
| D003863 | Depression |
| D013313 | Stress Disorders, Post-Traumatic |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D008722 | Methods |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D008919 | Investigative Techniques |
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