Treating Cancer-Related Fatigue Through Systematic Light Exposure
关键词
抽象
描述
Cancer related fatigue (CRF) - a persistent sense of exhaustion related to cancer or cancer treatment - can severely interfere with activities of daily living, and has even been reported to be a factor in patient requests for hastened death. CRF can represent a serious clinical problem years after all treatment has ended. In our research with cancer survivors 1 to 3 years after completion of hematopoietic stem cell transplant (HSCT), 40% of those we interviewed reported that CRF was a major obstacle to the resumption of usual activities. Despite its impact on quality of life, CRF is under-reported, under-diagnosed, and under-treated.
A variety of pharmacologic agents have been studied to treat CRF, but there is insufficient evidence to recommend their use. The most promising non-pharmacologic interventions -- exercise and cognitive-behavior therapy (CBT) -- have shown equally modest effects. The proposed study focuses on a promising new intervention for CRF, using systematic light exposure (SLE), consisting of a daily 30-minute exposure to as much as 10,000 lux of light from a commercially available light box. Study collaborator, Ancoli-Israel and her colleagues have successfully piloted this line of research with breast cancer patients undergoing chemotherapy.
The goal of this study will be to assess the effect of SLE on long-term HSCT and breast cancer survivors, and to determine the feasibility and acceptability of SLE as an intervention for CRF. The approach will be informed by the procedures that Ancoli-Israel and her colleagues developed for their research on SLE treatment for breast cancer chemotherapy, as well as by Redd's studies of CBT to treat adjustment disorders in survivors of HSCT. The study arms will test the efficacy of two different types of light treatment, bright white light and dim red light. Outcomes will be assessed through standardized measures of CRF, sleep quality, and quality of life.
日期
| 最后验证: | 03/31/2017 |
| 首次提交: | 06/05/2013 |
| 提交的预估入学人数: | 06/05/2013 |
| 首次发布: | 06/09/2013 |
| 上次提交的更新: | 04/06/2017 |
| 最近更新发布: | 04/10/2017 |
| 实际学习开始日期: | 12/31/2011 |
| 预计主要完成日期: | 06/30/2014 |
| 预计完成日期: | 06/30/2014 |
状况或疾病
干预/治疗
Device: Bright white light
Device: Dim red light
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Bright white light using systematic light exposure (SLE), consisting of a daily 30-minute exposure to as much as 10,000 lux of light from a commercially available light box | Device: Bright white light |
| Active Comparator: Dim red light using systematic light exposure (SLE), consisting of a daily 30-minute exposure to as much as 10,000 lux of light from a commercially available light box | Device: Dim red light |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: Patients: - With a history of HSCT as treatment for hematological malignancies and related diseases and who are up to 3.5 years post-transplant; OR - Who are up to three and a half years post completion of chemotherapy OR chemotherapy and radiation for breast cancer with a curative intent; AND: - With a score equal to or less than 33 on the FACIT-Fatigue scale (see below) and no pre-existing anemia (Hb<10gm/dl); or a score equal to or greater than 43 on the Cognitive Failures Questionnaire - Who are currently over age 18 and at least age 16 at the time of HSCT or time of breast cancer treatment Exclusion Criteria: - Under age 18; - Pregnancy; - Confounding underlying medical illnesses; - History of mania (which is a contra-indication for light treatment) or current clinical depression; - And any other physical or psychological impairments including a sleep disorder diagnosis which would limit participation. |
结果
主要结果指标
1. FACIT-Fatigue Scale [Baseline]
2. FACIT-Fatigue Scale [at 4 weeks]
3. FACIT-Fatigue Scale [at 3 months follow up]
次要成果指标
1. The Pittsburgh Sleep Quality Index [Baseline]
2. The Pittsburgh Sleep Quality Index [at 4 weeks]
3. The Pittsburgh Sleep Quality Index [at 3 months follow up]
4. SF-36 Scale [Baseline]
5. SF-36 Scale [at 4 weeks]
6. SF-36 Scale [at 3 months follow up]
7. CNS-Vital Signs [Baseline]
8. CNS-Vital Signs [at 4 weeks]
9. CNS-Vital Signs [at 3 months follow up]
10. The Cognitive Failures Questionnaire [Baseline]
11. The Cognitive Failures Questionnaire [at 4 weeks]
12. The Cognitive Failures Questionnaire [at 3 months follow up]
13. Brief Symptom Inventory-18 [Baseline]
14. Brief Symptom Inventory-18 [at 4 weeks]
15. Brief Symptom Inventory-18 [at 3 months follow up]
16. Actiwatch Spectrum [Baseline]
17. Actiwatch Spectrum [at 4 weeks]
18. Actiwatch Spectrum [at 3 months follow up]
