Effects of MSC Intervention on the Dyadic Mental Health of Lung Cancer Patients and Their Caregivers

The study was a single blind, follow-up, randomized, controlled trial. Researchers recruited subjects from two general tertiary hospitals in Changsha, Hunan province, China. And the whole trail was on the basis of the CONSORT statements. The two hospitals provided similar conventional care for lung cancer patients. Study procedures were approved by the institutional review boards of all participating centers before data collection began. All patients were screened by researchers for eligibility and then enrolled in the study if eligible and if the provided consent.

Potential eligible participants were identified by researchers according to medical records at the colorectal surgery unit in each hospital. The participants were recruited with informed consent, and researchers explained the study purposes, procedures, benefits, and risks involved orally. The participants were then randomly allocated to the intervention or the control group according to a computer-generated block randomization list. A sequentially numbered and opaque , sealed envelope system was used by a non-investigator. The generated random numbers were put into consecutively numbered and opaque sealed envelopes. When enrolling and randomising a new participant, the enrolling investigators opened the sealed envelope after participant's name was written on next available envelopes; the enrolling investigators were blinded to the trial design and study hypotheses.

The researcher will recruit 74 lung cancer patient-caregiver dyads and randomly divide them into 2 groups: the control group, the dyadic intervention group. Among them, patients in the control group and caregivers received routine psychological care programs; patients in the intervention group had access to conventional care, in addition to receiving the 8-week dyadic MSC intervention sessions. The intervention was provided by trained nurses, including one researcher and one MSC therapist. The researcher was regarded as primary leader of the intervention sessions. The leader informed patients of the schedule for each session using the educational manual'Caring for ourselves, we are together' (developed by psychologists, nursing managers, experienced MSC therapist, oncology Nurse, and researchers).

The MSC techniques include body scanning, breathing meditation, sitting meditation, walking meditation, loving-kindness practice, and self-compassion writing expression. Intensive training once a week, 1 hour each time, encourage students to use 15-20 minutes a day to learn these skills, the total training time per week is 2.5 hours. The intervention is mainly out-of-hospital intervention, supplemented by short-term in-hospital intervention (1-2 weeks, adjusted according to the patient's hospital stay). The in-hospital stage focuses on guiding the research subjects to understand the content of mindful self-compassion and emotions, and conduct basic mindful self-compassion training; the outside of the hospital focuses on the maintenance of mindful self-compassion training and the promotion of mindful life.

Data were collected by a research assistant who was blind to the study design and allocation of participants. At baseline, before randomization, sociodemographic and clinical characteristics were collected from medical records and personal interviews. The two groups of participants completed surveys after each follow-up via face to face interviews at baseline (T0) and immediately after intervention (T1). The next two evaluations were performed at 1-month (T2) and 3-months (T3) after intervention via telephone contact.

For lung cancer patients

Inclusion criteria

• Diagnosed with lung cancer by pathological biopsy or cytology;
• The disease condition is relatively stable;
• Must be conscious, with normal communication ability;
• Must be volunteered to join the study.

Exclusion criteria

• Share a hospital room with a current study participant;
• With other types of cancer;
• Alcoholics and/or drug addicts;
• Disabilities and cannot take care of themselves.

For caregivers

Inclusion criteria

• A primary caregiver designated by a lung cancer patient who has been included in this study, with a cumulative care time of more than 72 hours;
• One of the family members of a hospitalized lung cancer patient, such as their spouse, children, parents or other relatives
• must be conscious, with normal communication ability;
• must be volunteered to join the study.

Exclusion criteria

• Have an employment relationship with the patient, such as nurses and nanny；
• Alcoholics and/or drug addicts;
• Disabilities and cannot take care of themselves.