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Mindfulness to Enhance Quality of Life and Support Advance Care Planning (MEANING)

2020年8月10日 更新者：Shelley Johns、Indiana University

Mindfulness to Enhance Quality of Life and Support Advance Care Planning (MEANING): A Randomized Controlled Pilot Trial for Adults With Metastatic Cancer and Their Family Caregivers

The MEANING trial is a randomized controlled mixed methods pilot designed to compare a novel mindfulness meditation-based intervention (MEANING) to usual care for adults with advanced-stage solid malignancies and their family caregivers.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

Mindfulness meditation practices have reduced emotional distress, avoidant coping, and improved spiritual well-being in adult cancer patients. These beneficial effects may occur through present-moment acceptance of unpleasant thoughts, feelings, and circumstances and adaptive coping through self-awareness, self-regulation, and self-transcendence. Most mindfulness trials in cancer have focused on early-stage survivors; however, preliminary evidence suggests that mindfulness may help reduce distress in patients with advanced cancer and their family caregivers (FCGs).

Sixty patients with an advanced-stage solid malignancy and their FCGs (60 dyads) will be randomized in equal numbers to receive either the 6-week mindfulness intervention or usual care. Both groups will receive standard cancer care throughout the study period. Dyads randomized to the mindfulness arm will learn mindfulness meditation practices (e.g., body scan, sitting meditation) and mindful communication practices to enhance quality of life, support advance care planning engagement, and improve a variety of secondary outcomes.

The study will use a mixed methods 2-arm randomized design to examine the effects of the mindfulness intervention compared to usual care and seek to explain trial results using insights gleaned from post-intervention qualitative interviews.

研究の種類

介入

入学 (実際)

108

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Indiana
      • Indianapolis、Indiana、アメリカ、46202
        • Indiana University

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria-Patients

  • Patient is at least 18 years of age.
  • Patient is at least 3 weeks post-diagnosis of an incurable (locally advanced or metastatic) solid malignancy.
  • Patient's attending medical oncologist would not be surprised if the patient died in the next 12 months.
  • Patient has not completed a POST form.
  • Patient scores ≥ 7 on the Mini-Mental Adjustment to Cancer cognitive avoidance subscale.
  • Patient is willing and able to consent and travel to the class location for 6 weekly 2-hour sessions.
  • Patient has a family member or close friend eligible and interested in participating in the study.
  • Patient has adequate English fluency for completion of data collection

Inclusion Criteria-Family Care Givers (FCG)

  • FCG is at least 18 years of age.
  • FCG has been invited to participate in the trial with a patient who meets eligibility criteria above.
  • FCG is willing and able to consent and travel to the class location for 6 weekly 2-hour sessions.
  • FCG has adequate English fluency for completion of data collection

Exclusion Criteria-Patients

  • Patient reports a score of > 2 on the Activities and Function item from the Patient Generated Subjective Global Assessment91 (PG-SGA; the patient-reported version of the Eastern Cooperative Oncology Group score).
  • Patient makes 3 or more errors on a validated 6-item cognitive screener or exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and study participation.
  • Currently receiving hospice care (patients who enroll in hospice during the trial will have the option of continuing trial participation).

Exclusion Criteria-FCGs

• FCG exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and study participation.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：支持療法
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
介入なし：Usual Care
Participants assigned to Usual Care will continue to receive standard care from their oncology team, including access to supportive care from oncology social workers. At the end of the study, usual care dyads will receive a packet of informational materials on mindfulness meditation, receive a CD with 5 mindfulness meditation practices, and meet with the study interventionist for guidance on how to use the materials and mindfulness recordings to their advantage in coping with cancer-related challenges.
アクティブコンパレータ：Mindfulness
The Mindfulness intervention will consist of six 2-hour sessions that will include guided mindfulness practices, didactics, and group discussion. The course curriculum is modeled on the Mindfulness-Based Stress Reduction program which involves intensive experiential training of participants in secular mindfulness meditation practices (i.e., body scan, sitting meditation, gentle hatha yoga with chair adaptations, compassion meditation), with an emphasis on embodying interpersonal mindfulness in dialogue.
行動：Mindfulness
The Mindfulness intervention sessions are designed to cultivate present-moment awareness in everyday life to facilitate adaptive and non-reactive relating to thoughts, feelings, and bodily sensations. Participants will be provided with 10-20 minute audio recordings of each of 5 mindfulness practices covered in class, recorded in the facilitator's voice. Participants will be encouraged to practice mindfulness at home 10-20 minutes per day, 6 days per week. Participants will be provided with weekly diaries on which to record type and amount of home practice of mindfulness skills.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change from baseline in quality of life (QoL) for Patients
時間枠：Baseline, 6 weeks, and 10 weeks
QoL for patients will be assessed with the McGill Quality of Life Inventory.
Baseline, 6 weeks, and 10 weeks
Change from baseline in quality of life (QoL) for Family Caregivers
時間枠：Baseline, 6 weeks, and 10 weeks
QoL for family caregivers will be assessed with the Caregiver Quality of Life - Cancer scale (CQoLC).
Baseline, 6 weeks, and 10 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Change from baseline in advance care planning (ACP) stage of change
時間枠：Baseline, 6 weeks, and 10 weeks
ACP stage of change will be assessed by a measure modified from Fried et. al assessing stage of change for 3 advance care planning behaviors (completing a living will, medical power of attorney form, or POLST form; patient only measure).
Baseline, 6 weeks, and 10 weeks
Change from baseline in advance care planning (ACP) engagement
時間枠：Baseline, 6 weeks, and 10 weeks
ACP engagement (self-efficacy, readiness) will be measured using 2 subscales of the Advance Care Planning Engagement Survey (patient only measure).
Baseline, 6 weeks, and 10 weeks
Change from baseline in caregiver burden
時間枠：Baseline, 6 weeks, and 10 weeks
Caregiver burden will be measured using the Zarit Burden Interview (family caregiver measure only)
Baseline, 6 weeks, and 10 weeks
Change from baseline in avoidant coping
時間枠：Baseline, 6 weeks, and 10 weeks
Avoidant coping will be assessed using the Mini-MAC Cognitive Avoidance subscale
Baseline, 6 weeks, and 10 weeks
Change from baseline in avoidant coping
時間枠：Baseline, 6 weeks, and 10 weeks
Avoidant coping will be assessed using the Brief COPE Self-Distraction, Denial, and Behavioral Disengagement subscales
Baseline, 6 weeks, and 10 weeks
Change from baseline in depressive symptoms
時間枠：Baseline, 6 weeks, and 10 weeks
Depressive symptoms will be assessed using the PHQ-8
Baseline, 6 weeks, and 10 weeks
Change from baseline in anxiety
時間枠：Baseline, 6 weeks, and 10 weeks
Anxiety will be assessed using the GAD-7
Baseline, 6 weeks, and 10 weeks
Change from baseline in spiritual well-being
時間枠：Baseline, 6 weeks, and 10 weeks
Spiritual well-being will be measured using the FACIT-SP.
Baseline, 6 weeks, and 10 weeks
Change from baseline in sleep disturbance
時間枠：Baseline, 6 weeks, and 10 weeks
Sleep disturbance will be assessed using the PROMIS Sleep Disturbance.
Baseline, 6 weeks, and 10 weeks
Change from baseline in family communication
時間枠：Baseline, 6 weeks, and 10 weeks
Family communication will be assessed using the Social Constraint Scale
Baseline, 6 weeks, and 10 weeks
Change from baseline in interpersonal closeness
時間枠：Baseline, 6 weeks, and 10 weeks
Interpersonal closeness will be assessed using the Perceived Interpersonal Closeness Scale.
Baseline, 6 weeks, and 10 weeks
Change from baseline in acceptance of illness
時間枠：Baseline, 6 weeks, and 10 weeks
Acceptance of illness will be assessed using the PEACE Scale.
Baseline, 6 weeks, and 10 weeks
Change from baseline in mindfulness
時間枠：Baseline, 6 weeks, and 10 weeks
Mindfulness will be assessed using the FFMQ-SF Non-reactivity to Internal Experience and Acting with Awareness subscales.
Baseline, 6 weeks, and 10 weeks
Distress Thermometer
時間枠：Baseline, 6 weeks, and 10 weeks
Distress will be assessed using the Distress Thermometer.
Baseline, 6 weeks, and 10 weeks
Intervention satisfaction and helpfulness
時間枠：6 weeks
Satisfaction and helpfulness with the Mindfulness intervention will be assessed using single-item investigator-created 7- and 10-point Likert scales, respectively (Mindfulness group only).
6 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Indiana University

捜査官

  • 主任研究者：Shelley A Johns, PsyD、Indiana University School of Medicine

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2017年5月9日

一次修了 (実際)

2017年12月11日

研究の完了 (実際)

2017年12月11日

試験登録日

最初に提出

2017年8月16日

QC基準を満たした最初の提出物

2017年8月17日

最初の投稿 (実際)

2017年8月22日

学習記録の更新

投稿された最後の更新 (実際)

2020年8月12日

QC基準を満たした最後の更新が送信されました

2020年8月10日

最終確認日

2020年8月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 1702223546

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