Quality of Life Interventions During Cervical Cancer Treatment

University of Iowa

Status: Completed

Conditions: Cervical Cancer

Treatments: Other: Ancillary studies; Behavioral: Relaxation training; Behavioral: Therapeutic touch; Other: Questionnaire administration

Study type: Interventional

Funder types: Other

Identifiers

NCT04905576

200105058

Details and patient eligibility

About

The proposed project will examine the effects of a healing touch intervention in women receiving chemotherapy and radiation for advanced cervical cancer.

Full description

Patients receiving chemoradiation for cervical cancer are at risk for distress, chemoradiation-related side effects, and immunosuppression. This prospective randomized clinical trial proposes to examine the effects of a complementary therapy, Healing Touch (HT), versus relaxation training (RT) and usual care (UC) for (1) supporting cellular immunity, (2) improving mood and quality of life (QOL), and (3) reducing treatment-associated toxicities and treatment delay in cervical cancer patients receiving chemoradiation.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with stage I-IVa cervical cancer pursuing concurrent chemotherapy and radiation therapy.

Exclusion criteria

• Greater than Stage IVa cervical cancer
• Metastatic or recurrent cervical cancer
• Patients receiving only chemotherapy or only radiation therapy
• History of cancer of any site
• History of a transplant
• Diagnosed with any immunosupressive disorder (HIV, AIDS).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 3 patient groups

Relaxation training following daily radiation

Experimental group

Description:

All relaxation sessions will be given individually, and will be provided by trained nurses or research assistants. Patients receiving relaxation will learn exercises to release tension through muscle relaxation, breathing, and imagery

Treatment:

Other: Questionnaire administration

Behavioral: Relaxation training

Other: Ancillary studies

Healing touch therapy following daily radiation

Experimental group

Description:

All Healing Touch sessions will be given individually, and will be provided by trained nurses or research assistants. Patients receiving Healing Touch will receive a series of standardized therapeutic techniques designed to promote optimal flow of energy throughout the body.

Treatment:

Other: Questionnaire administration

Behavioral: Therapeutic touch

Other: Ancillary studies

No intervention

Active Comparator group

Description:

The no intervention group will receive no special intervention other than standard medical care, which includes the regular medical care given by the patient's physician and health care professionals.

Treatment:

Other: Questionnaire administration

Other: Ancillary studies