NL-OMON51707招募中不适用
COMPANION study: A pilot trial testing couple mindfulness-based cognitive behavioral therapy via internet targeting cancer-related fatigue [workpackage 2] - COMPANION study 2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Only couples are eligible for participation. In order to be eligible, the
- •couple must meet each of the following criteria:
- •1. the patient has a cancer diagnosis (all malignancies will be included) as
- •confirmed with the medical (GP) record;
- •2. the patient completed cancer treatment with either curative or palliative
- •intent >= 3 months earlier. Patients who currently receive hormone therapy are
- •3. the patient experiences severe levels of fatigue (score of >= 35 on the
- •CIS-Subjective Fatigue [CIS-SF] subscale);
- •4. the patient has been suffering from severe fatigue for >= 3 months (as
- •self-reported by the patient);
- •5. the patient was >= 18 years old at disease onset;
- •6. the partner is >= 18 years old;
- •7. both couple members live together;
- •8. both couple members have good command of the Dutch language (checked
- •implicitly during registration);
- •9. both couple members have adequate computer literacy and have access to an
- •internet-connected computer, laptop or tablet (based on self-report);
- •10. both couple members agree to participate in the research.
排除标准
- •The couple will be excluded in case:
- •1. the patient is currently following an evidence-based therapy for CCRF (i.e.
- •CBT, mindfulness-based therapy, exercising/physiotherapy) as self-reported at
- •the (telephone) screening;
- •2. the patient suffers from a condition that can explain his/her fatigue and is
- •potentially treatable (e.g. anemia), as checked with the medical record;
- •3. the therapist decides, based on information collected during the intake
- •session, that the intervention is not suitable for the couple. Criteria that
- •will be considered include, but are not limited to:
- •- presence of severe psychiatric morbidity such as suicidal ideation and/or
- •psychosis (as assessed by the therapist at the intake session). Mild depression
- •is not an exclusion criterion. A score of >= 20 on the HADS at T0 is considered
- •indicative of depression (Le Fevre, Devereux, Smith, Lawrie, & Cornbleet,
- •1999). Therefore, if the patient or the partner scores >= 20, the therapist will
- •determine at the intake whether the participant has suicidal ideation or
- •suffers from other severe psychiatric morbidity. A participant (and thus the
- •couple) will be excluded if, according to the therapist, that is the case;
- •- presence of substance abuse, except for smoking.
- •If a couple gets excluded due to somatic or psychiatric problems of one or both
- •partners, a referral to GP will take place.
研究者
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