Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00230711
Status:
COMPLETED
Last Update Posted:
2012-11-30
First Post:
2005-09-29
Brief Title:
Physical Activity Promotion in Cancer Follow-Up Care
Sponsor:
The Miriam Hospital
Organization:
The Miriam Hospital
Study Overview
Official Title:
Physical Activity Promotion In Cancer Follow-up Care
Status:
COMPLETED
Status Verified Date:
2005-09
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:
This study aims at testing the efficacy of a physical activity PAintervention in an outpatient oncology setting We plan to compare Brief Advice for PA MD advice plus contact control vs Extended Advice MD advice plus telephone-based PA counseling by research staff over 3 months among 300 women who have completed treatment for breast cancer in the past 2 years
Specific Aims The primary aim is to examine the effects of oncologists advice on PA plus telephone counseling Extended Advice vs oncologists advice Brief Advice alone on minutes of moderate-intensity PA at 3 months among 300 sedentary women who have completed treatment for breast cancer
Secondary aims include examining a the effects of the two interventions on participants moderate-intensity PA at 6 and 12 months b the effects of the interventions on participants physical functioning fatigue vigor and quality of life QOL at 3 6 and 12 months and c the acceptability of the interventions to the oncologists and the usefulness of the interventions to patients
Specific Aims The primary aim is to examine the effects of oncologists advice on PA plus telephone counseling Extended Advice vs oncologists advice Brief Advice alone on minutes of moderate-intensity PA at 3 months among 300 sedentary women who have completed treatment for breast cancer
Secondary aims include examining a the effects of the two interventions on participants moderate-intensity PA at 6 and 12 months b the effects of the interventions on participants physical functioning fatigue vigor and quality of life QOL at 3 6 and 12 months and c the acceptability of the interventions to the oncologists and the usefulness of the interventions to patients
Detailed Description:
Background With improved survival rates there are growing numbers of cancer survivors These individuals report impaired physical functioning anxiety and depressed mood fatigue and reduced quality of life after treatment In addition they may be at increased risk for cardiovascular disease obesity osteoporosis and future cancers Prior research has demonstrated that moderate-intensity physical activity PA can improve enhance physical functioning reduce fatigue and improve vigor among cancer patients and those who have completed medical treatments These efforts have not been integrated with the healthcare system Data support the role of primary care providers in promoting PA among their sedentary patients the role of oncologists in encouraging patients to become physically active has not been examined
Objectives This study aims at testing the efficacy of a PA intervention in an outpatient oncology setting We plan to compare Brief Advice for PA MD advice plus contact control vs Extended Advice MD advice plus telephone-based PA counseling by research staff over 3 months among 300 women who have completed treatment for breast cancer in the past 2 years
Specific Aims The primary aim is to examine the effects of oncologists advice on PA plus telephone counseling Extended Advice vs oncologists advice Brief Advice alone on minutes of moderate-intensity PA at 3 months among 300 sedentary women who have completed treatment for breast cancer
Secondary aims include examining a the effects of the two interventions on participants moderate-intensity PA at 6 and 12 months b the effects of the interventions on participants physical functioning fatigue vigor and quality of life QOL at 3 6 and 12 months and c the acceptability of the interventions to the oncologists and the usefulness of the interventions to patients
Study Design A randomized controlled trial will be conducted in outpatient oncology practices in Rhode Island Within this setting the oncologists and research staff will offer a 3 month theoretically-based intervention to increase moderate-intensity PA among 300 sedentary women aged 18 and older who attend cancer follow-up visits The unit of randomization will be at the patient level
Cancer Relevance If the data are promising the study lays the groundwork for improving cancer recovery by integrating a brief PA intervention into follow-up care for cancer survivors This study offers the potential to improve the follow-up care for cancer survivors by encouraging them to becoming physically active to help reduce the emotional and physical side-effects of cancer and its treatment as well as possibly reduce their risk for other chronic diseases such as cardiovascular disease and osteoporosis
Objectives This study aims at testing the efficacy of a PA intervention in an outpatient oncology setting We plan to compare Brief Advice for PA MD advice plus contact control vs Extended Advice MD advice plus telephone-based PA counseling by research staff over 3 months among 300 women who have completed treatment for breast cancer in the past 2 years
Specific Aims The primary aim is to examine the effects of oncologists advice on PA plus telephone counseling Extended Advice vs oncologists advice Brief Advice alone on minutes of moderate-intensity PA at 3 months among 300 sedentary women who have completed treatment for breast cancer
Secondary aims include examining a the effects of the two interventions on participants moderate-intensity PA at 6 and 12 months b the effects of the interventions on participants physical functioning fatigue vigor and quality of life QOL at 3 6 and 12 months and c the acceptability of the interventions to the oncologists and the usefulness of the interventions to patients
Study Design A randomized controlled trial will be conducted in outpatient oncology practices in Rhode Island Within this setting the oncologists and research staff will offer a 3 month theoretically-based intervention to increase moderate-intensity PA among 300 sedentary women aged 18 and older who attend cancer follow-up visits The unit of randomization will be at the patient level
Cancer Relevance If the data are promising the study lays the groundwork for improving cancer recovery by integrating a brief PA intervention into follow-up care for cancer survivors This study offers the potential to improve the follow-up care for cancer survivors by encouraging them to becoming physically active to help reduce the emotional and physical side-effects of cancer and its treatment as well as possibly reduce their risk for other chronic diseases such as cardiovascular disease and osteoporosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| RSGP-03-423 | None | None | None |