Alberts 2008.
| Trial name or title | Diet and physical activity change or usual care in improving survival in patients with previously treated stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer |
| Methods | Randomised phase III trial |
| Participants | Patients with previously treated stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer. After treatment, participants will be randomised to either healthy lifestyle counselling or usual care |
| Interventions |
Group 1: (lifestyle intervention) Participants receive a dietary intervention designed to promote increased levels of plasma carotenoids, to control weight, and to ensure adequacy of micronutrient intake. Participants also undergo a physical activity intervention comprising a moderately low aerobic regimen, face‐to‐face counselling on how to read food labels to estimate grams of fat per serving, and telephone counselling by a lifestyle intervention counsellor once a week for 4 weeks, then twice a month for 6 months, monthly for the subsequent 6 months, and then once every other month for 11 months. Participants complete daily fat gram and step diaries at least 3 times per week GROUP 2: (comparison lifestyle) Participants receive a study notebook containing general study‐related information. Participants are not asked to record diet or physical activity but are provided a single sample diary in their study notebook. Participants receive telephone contact on a sliding scale similar to the intervention group, but at less frequent intervals (22 vs 33 calls over the course of the intervention) After completion of the study, participants are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter |
| Outcomes | Biomarkers (e.g. total carotenoid), survival, compliance, QoL, bowel function, sleep duration/quality, anthropometry, dietary intake, telomere length Biomarkers to be measured at baseline and at 6, 12, and 24 months. After completion of the study, participants are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter |
| Starting date | July 2008 |
| Contact information | David Alberts |
| Notes |