Internet-Based Weight-Loss Program for Colorectal Cancer Survivors
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Cancer, Cancer, Cancer, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology, Oncology |
| Healthy: | No |
| Age Range: | 21 - 120 |
| Updated: | 7/15/2016 |
| Start Date: | July 2009 |
| End Date: | July 2017 |
Internet Weight Loss Intervention for Individuals Diagnosed With Colorectal Cancer
RATIONALE: A personalized Internet-based weight-loss program may help improve the quality of
life for colorectal cancer survivors.
PURPOSE: This randomized phase I trial is studying how well an Internet-based program works
in helping colorectal cancer survivors lose weight.
life for colorectal cancer survivors.
PURPOSE: This randomized phase I trial is studying how well an Internet-based program works
in helping colorectal cancer survivors lose weight.
OBJECTIVES:
- To evaluate the feasibility of implementing an Internet-based weight-loss intervention
for colorectal cancer (CRC) survivors.
- To obtain preliminary outcome data on the impact of an Internet-based intervention on
weight loss, waist circumference, physical activity, diet, weight-control strategies,
weight-loss intention, exercise and diet self-efficacy, and perceived weight-loss
barriers among CRC survivors.
- To obtain preliminary data on potential moderators (sociodemographics, disease and
treatment characteristics, prior Internet experience, depressive symptoms, dieting and
weight-loss experiences, weight-loss expectations, and physical activity and dietary
outcome expectancies) of weight loss among CRC survivors using an Internet-based
weight-loss intervention.
OUTLINE: Patients are stratified according to time since completion of cancer treatment (1
to 2 years vs 3 to 4 years vs 5 to 6 years vs 7 to 10 years). Patients are randomized to 1
of 2 intervention arms.
- Arm I (12-week Internet-based weight-loss intervention): Patients attend an in-person
60-minute session with a health educator. The health educator will review the patient's
weight history, current eating habits, prior and current level of physical activity,
reasons for wanting to lose weight, current weight, weight-loss goals, and barriers to
weight loss. The health educator will provide basic weight-loss advice for the patient,
according to established guidelines, and advice on diet modification to reduce caloric
intake. The health educator will also recommend gradual increases in physical activity
and help patients set a realistic target weight to achieve at the end of the 12-week
intervention period.
The health educator will introduce the intervention website to the patient and assist the
patient in setting up a confidential, unique login username and password that will provide
secure access to the study website. Patients are asked to provide an email address. After
logging onto the website and viewing an introductory page, patients are prompted to specify
their target weight for the end of the 12-week intervention and to provide a list of reasons
for wanting to lose weight. Next, the website prompts patients to list specific strategies
that they plan to use to achieve their desired weight loss. The health educator will guide
the patient in entering an initial set of strategies and will provide the patient a list of
examples of weight-loss strategies and encourage the patient to generate his/her own
specific, personalized strategies. Patients will also be able to select and adapt strategies
from the example list that they feel are appropriate for them. The health educator will
ensure that the patient is comfortable using the website and will give the patient a
one-page written summary of how to use the website and a phone number and an e-mail address
that they can use to receive technical help with the website. Additionally, patients are
advised to login to the website twice a week during the 12-week intervention period and are
prompted to report their weight, to review and update their reasons for weight loss, to
indicate their success with implementing each of their weight-loss strategies, to rate the
perceived effectiveness of each weight-loss strategy, and to revise or create new strategies
as needed. Patients will also receive automated e-mails that prompt them to visit the
website and that provide them with weight-loss tips and motivational messages. The website
also provides additional resources, including a list of credible external websites with
useful weight loss information and healthy recipes, a summary of weight-loss tips, tips for
creating appropriate weight-loss strategies, and examples of weight-loss strategies.
- Arm II (wait-list control): Patients are instructed to continue their usual dietary and
physical activity routines during a 12-week wait period. After the waiting period,
patients receive the Internet-based weight-loss intervention for 12 weeks as in arm I.
Patients in both arms complete surveys at baseline and at 12 weeks to assess
sociodemographics, disease and treatment characteristics, prior Internet experience,
depressive symptoms, weight, dieting and weight-loss experiences, weight-loss expectations,
and physical activity and dietary outcome expectancies. Patients in arm II also complete an
additional follow-up survey at 24 weeks.
- To evaluate the feasibility of implementing an Internet-based weight-loss intervention
for colorectal cancer (CRC) survivors.
- To obtain preliminary outcome data on the impact of an Internet-based intervention on
weight loss, waist circumference, physical activity, diet, weight-control strategies,
weight-loss intention, exercise and diet self-efficacy, and perceived weight-loss
barriers among CRC survivors.
- To obtain preliminary data on potential moderators (sociodemographics, disease and
treatment characteristics, prior Internet experience, depressive symptoms, dieting and
weight-loss experiences, weight-loss expectations, and physical activity and dietary
outcome expectancies) of weight loss among CRC survivors using an Internet-based
weight-loss intervention.
OUTLINE: Patients are stratified according to time since completion of cancer treatment (1
to 2 years vs 3 to 4 years vs 5 to 6 years vs 7 to 10 years). Patients are randomized to 1
of 2 intervention arms.
- Arm I (12-week Internet-based weight-loss intervention): Patients attend an in-person
60-minute session with a health educator. The health educator will review the patient's
weight history, current eating habits, prior and current level of physical activity,
reasons for wanting to lose weight, current weight, weight-loss goals, and barriers to
weight loss. The health educator will provide basic weight-loss advice for the patient,
according to established guidelines, and advice on diet modification to reduce caloric
intake. The health educator will also recommend gradual increases in physical activity
and help patients set a realistic target weight to achieve at the end of the 12-week
intervention period.
The health educator will introduce the intervention website to the patient and assist the
patient in setting up a confidential, unique login username and password that will provide
secure access to the study website. Patients are asked to provide an email address. After
logging onto the website and viewing an introductory page, patients are prompted to specify
their target weight for the end of the 12-week intervention and to provide a list of reasons
for wanting to lose weight. Next, the website prompts patients to list specific strategies
that they plan to use to achieve their desired weight loss. The health educator will guide
the patient in entering an initial set of strategies and will provide the patient a list of
examples of weight-loss strategies and encourage the patient to generate his/her own
specific, personalized strategies. Patients will also be able to select and adapt strategies
from the example list that they feel are appropriate for them. The health educator will
ensure that the patient is comfortable using the website and will give the patient a
one-page written summary of how to use the website and a phone number and an e-mail address
that they can use to receive technical help with the website. Additionally, patients are
advised to login to the website twice a week during the 12-week intervention period and are
prompted to report their weight, to review and update their reasons for weight loss, to
indicate their success with implementing each of their weight-loss strategies, to rate the
perceived effectiveness of each weight-loss strategy, and to revise or create new strategies
as needed. Patients will also receive automated e-mails that prompt them to visit the
website and that provide them with weight-loss tips and motivational messages. The website
also provides additional resources, including a list of credible external websites with
useful weight loss information and healthy recipes, a summary of weight-loss tips, tips for
creating appropriate weight-loss strategies, and examples of weight-loss strategies.
- Arm II (wait-list control): Patients are instructed to continue their usual dietary and
physical activity routines during a 12-week wait period. After the waiting period,
patients receive the Internet-based weight-loss intervention for 12 weeks as in arm I.
Patients in both arms complete surveys at baseline and at 12 weeks to assess
sociodemographics, disease and treatment characteristics, prior Internet experience,
depressive symptoms, weight, dieting and weight-loss experiences, weight-loss expectations,
and physical activity and dietary outcome expectancies. Patients in arm II also complete an
additional follow-up survey at 24 weeks.
DISEASE CHARACTERISTICS:
- Diagnosis of colorectal cancer (CRC)
- Stage I-III disease
- Completed treatment for CRC 1-10 years ago
- No current evidence of cancer
PATIENT CHARACTERISTICS:
- Not nursing
- Not pregnant within the past 6 months and not planning to become pregnant
- Speaks English
- Has access to the Internet at home or work
- Lives within 50 miles of Fox Chase Cancer Center (FCCC)
- Body mass index 25 to 35 kg/m^2
- No weight loss of ≥ 15 lbs within the past 6 months
- No history of eating disorder
- None of the following medical conditions:
- Myocardial infarction or stroke within the past 6 months
- Type I diabetes
- Uncontrolled hypertension
- Unstable angina
- Congestive heart failure
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent weight-loss medications (intervention phase)
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials