Trial Outcomes & Findings for Educational Program in Younger Women Who Have Recently Finished Treatment for Stage I or Stage II Breast Cancer (NCT NCT00416572)
NCT ID: NCT00416572
Last Updated: 2016-11-07
Results Overview
Scores for the shortened form of the Center for Epidemiologic Studies Depression scale(CES-D) ranged from 0 (no depressive symptoms) to 24 (high levels of depressives symptoms) in the present sample.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
252 participants
Primary outcome timeframe
Baseline, Post-intervention(4 months post-intervention) and Final Follow-up(13 months post-intervention).
Results posted on
2016-11-07
Participant Flow
Potential participants were identified through nurse referrals of consecutive and potentially eligible patients from hospital medical oncology clinics and physicians' offices in southwestern Pennsylvania.
Participant milestones
| Measure |
Education Intervention
Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants' uncertainty about their illness/treatment, to enhance coping in productive ways.
Sessions were led by two professionals with expertise in the topic. The sessions began a with presentation of informational material followed by guided discussion of related topics. The first session discussed what to say and not say to children about cancer; the second session discussed carrying on with life after the diagnosis of breast cancer, including strategies for managing stress and anxiety and developing meaning in life; the third session talked about how to maintain closeness with a partner and ways to talk about breast cancer; the last session focused on the effects of treatment on reproductive status, and the genetic bases of breast cancer. Participants were also given related booklets and brochures to take home to read.
|
Nutrition Education Intervention
Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
The nutrition sessions were presented by a professional trained in nutritional science. Sessions included the presentation of information and guided discussion of related topics. The first session discussed information on choosing fruits, vegetables, and low-fat foods and incorporating them into a diet; the second session involved a demonstration of low-fat cooking methods; the third session provided information on the nutritional make-up of a healthy diet and how to shop for it; the last session included information on how to maintain a healthy, low-fat diet while eating out. Women were also asked to keep a four-day food diary, to focus them on their dietary intake and control over it.
|
Control Condition
Participants received care as usual.
|
|---|---|---|---|
|
Overall Study
STARTED
|
83
|
85
|
84
|
|
Overall Study
COMPLETED
|
70
|
78
|
76
|
|
Overall Study
NOT COMPLETED
|
13
|
7
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Educational Program in Younger Women Who Have Recently Finished Treatment for Stage I or Stage II Breast Cancer
Baseline characteristics by cohort
| Measure |
Education Intervention
n=83 Participants
Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants' uncertainty about their illness/treatment, to enhance coping in productive ways.
|
Nutrition Education Intervention
n=85 Participants
Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
|
Control Condition
n=84 Participants
Participants received care as usual.
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.7 years
n=5 Participants
|
44.2 years
n=7 Participants
|
44.6 years
n=5 Participants
|
44.2 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
252 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
79 participants
n=5 Participants
|
80 participants
n=7 Participants
|
82 participants
n=5 Participants
|
241 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African-American
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Post-intervention(4 months post-intervention) and Final Follow-up(13 months post-intervention).Population: All women who agreed to random assignment and completed all three assessments were retained in the analysis regardless of their level of group attendance.
Scores for the shortened form of the Center for Epidemiologic Studies Depression scale(CES-D) ranged from 0 (no depressive symptoms) to 24 (high levels of depressives symptoms) in the present sample.
Outcome measures
| Measure |
Education Intervention
n=70 Participants
Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants' uncertainty about their illness/treatment, to enhance coping in productive ways.
|
Nutrition Education Intervention
n=78 Participants
Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
|
Control Condition
n=76 Participants
Participants received care as usual
|
|---|---|---|---|
|
Depressive Symptoms (Measured With an Abbreviated 10-item CES-D) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention).
Baseline
|
5.83 units on a scale
Standard Deviation 5.32
|
6.74 units on a scale
Standard Deviation 5.94
|
6.70 units on a scale
Standard Deviation 5.84
|
|
Depressive Symptoms (Measured With an Abbreviated 10-item CES-D) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention).
Post-intervention
|
5.65 units on a scale
Standard Deviation 5.53
|
5.70 units on a scale
Standard Deviation 5.45
|
6.87 units on a scale
Standard Deviation 5.84
|
|
Depressive Symptoms (Measured With an Abbreviated 10-item CES-D) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention).
Final follow-up
|
5.07 units on a scale
Standard Deviation 4.99
|
4.36 units on a scale
Standard Deviation 4.49
|
6.88 units on a scale
Standard Deviation 6.19
|
PRIMARY outcome
Timeframe: Baseline, Post-intervention(4 months post-intervention), and Final Follow-up(13 months post-intervention)Population: All women who agreed to random assignment and completed all three assessments were retained in the analysis regardless of their level of group attendance.
The Perceived Physical Health Component scale of the Medical Outcomes Study Short Form 36 (SF-36) consists of a norm-based weighted average of the following subscales: Physical functioning, bodily pain, role limitations due to physical problems and general health. In the present study, scores ranged from a maximum of 68 (high levels of perceived health) to a minimum of 24 (low levels of perceived health).
Outcome measures
| Measure |
Education Intervention
n=70 Participants
Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants' uncertainty about their illness/treatment, to enhance coping in productive ways.
|
Nutrition Education Intervention
n=78 Participants
Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
|
Control Condition
n=76 Participants
Participants received care as usual
|
|---|---|---|---|
|
Perceived Physical Health (Measured With SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)
Baseline
|
49.21 units on a scale
Standard Deviation 8.19
|
50.38 units on a scale
Standard Deviation 8.26
|
49.16 units on a scale
Standard Deviation 8.26
|
|
Perceived Physical Health (Measured With SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)
Post-intervention
|
52.03 units on a scale
Standard Deviation 7.02
|
53.59 units on a scale
Standard Deviation 6.18
|
50.73 units on a scale
Standard Deviation 9.07
|
|
Perceived Physical Health (Measured With SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)
Final follow-up
|
55.11 units on a scale
Standard Deviation 7.12
|
53.90 units on a scale
Standard Deviation 5.55
|
50.93 units on a scale
Standard Deviation 9.14
|
PRIMARY outcome
Timeframe: Baseline, Post-intervention(4 months post-intervention), Final Follow-up(13 months post-intervention)Population: All women who agreed to random assignment and completed all three assessments were retained in the analysis regardless of their level of group attendance.
The Mental Health Component Scale of the Medical Outcomes Study Short Form 36 (SF-36) consists of a norm-based weighted average of the following subscales: vitality, social functioning, role limitations due to emotional problems and mental health. In the present study, scores ranged from a maximum of 68 (high levels of mental health) to a minimum of 15 (low levels of mental health).
Outcome measures
| Measure |
Education Intervention
n=70 Participants
Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants' uncertainty about their illness/treatment, to enhance coping in productive ways.
|
Nutrition Education Intervention
n=78 Participants
Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
|
Control Condition
n=76 Participants
Participants received care as usual
|
|---|---|---|---|
|
Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)
Baseline
|
45.63 units on a scale
Standard Deviation 10.77
|
46.91 units on a scale
Standard Deviation 11.18
|
45.76 units on a scale
Standard Deviation 10.69
|
|
Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)
Post-Intervention
|
50.47 units on a scale
Standard Deviation 9.13
|
50.38 units on a scale
Standard Deviation 9.06
|
49.27 units on a scale
Standard Deviation 9.06
|
|
Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)
Final Follow-up
|
48.64 units on a scale
Standard Deviation 10.72
|
51.26 units on a scale
Standard Deviation 8.27
|
49.48 units on a scale
Standard Deviation 8.27
|
Adverse Events
Education Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nutrition Education Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place